OTC-Monograph by Prof. Dr. Mohsen Afouna

OTC Active Ingredients

UNII Code 18B8O9DQA2

5QB0T2IUN0 U3RSY48JW5 8SKN0B0MIM W9WZN9A0GM R57ZHV85D4 210100728E 5TJD82A1ET BPF36H1G6S LJ25TI0CVT BPF36H1G6S R533ES02EC Z3D4AJ1R48 2DI9HA706A 6M2P64V0NC DE08037SAB 339NCG44TV 4NC0T56V35 28A37T47QO 85H0HZU99M R35D29L3ZA YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK O414PZ4LPZ O414PZ4LPZ 91MBZ8H3QO HX1032V43M 70FD1KFU70 70FD1KFU70 5NF5D4OPCI 3J50XA376E H4N855PNZ1 SOI2LOH54Z H92E6QA4FV 89DS0H96TB 2P3VWU3H10

Active Ingredient alcloxa alkyl isoquinolinium bromide aluminum chlorohydrex aluminum hydroxide benzocaine benzoic acid benzoyl peroxide boric acid calcium polysuldfide calcium thiosulfate camphor chlorhydroxyquinoline (cloxyquin) chloroxylenol cloxyquin (chlorhydroxyquinoline) coal tar dibenzothiophene estrone magnesium aluminum silicate magnesium sulfate phenol phenolate sodium phenyl salicylate povidone-iodine pyrilamine maleate resorcinol (as single ingredient only) resorcinol (when combined with sulfur) resorcinol monoacetate (as single ingredient only) resorcinol monoacetate (when combined with sulfur) salicylic acid salicylic acid (over 2 up to 5%) sodium borate sodium thiosulfate sulfur sulfur (when combined w/ resorcinol, resocinol monoacetate) tetracaine hydrochloride thymol vitamin E zinc oxide zinc stearate zinc sulfide charcoal, activated

Monograph acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acne acute toxic ingestion

April 7, 2010

Sub-category

Panel II II II II II II I II II II II II II

Pending II II II II II II I-> IIIS II II II II II II

II II II

II II II II III II III

II II II II III II II

III

III III II II I I II II II II II II

I III II II I I II III II II II II I

Final 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 333.310(a) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 333.310(b) 310.545(a)(1) 333.310(c) 333.310(d) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 333.310(e) 333.310(f) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1) 310.545(a)(1)

FR Citation

75 FR 9767

OTC Active Ingredients

UNII Code ND2M416302 5TJD82A1ET LT10EIP3A 2456GO94TR 70C1507JU9 7C0697DR9I WQZ3G9PF0H R57ZHV85D5 658O6T0WXZ 339NCG44TV YUL4LO94HK WIQ1H85SYP 28F9E0DJY6 1014J0U34 SOI2LOH54Z 5TJD82A1ET 658O6T0WXZ LT10EIP3A XJ6RUH0046 18B8O9DQA2 70FD1KFU70 YUL4LO94HK 70FD1KFU70 U3RSY48JW6 LKG8494WBH L6JW2TJG99 Z97702A5DG ZEC193879Q 98PI200987 88AYB867L5 0619F35CGV 5NF5D4OPCI IOS9HV04K7 514B9K0L10

3NY3SM6B8U 9936O846LI

Active Ingredient isopropyl alcohol camphor juniper tar menthol diperodon phenacaine hydrochloride atropine belladonna extract boric acid boroglycerin hydrastis phenol resorcinol sodium salicylic acid phenolate calamine tannic acid witch hazel (haramelis water) zinc oxide camphor hydrastis menthol turpentine oil (rectified) alcloxa precipitated sulfur resorcinol sublimed sulfur benzocaine benzyl alcohol dibucaine dibucaine hydrochloride dyclonine hydrochloride lidocaine pramoxine hydrochloride tetracaine tetracaine hydrochloride collinsonia extract Escherichia coli vaccine lappa extract leptandra extract live yeast cell derivative mullein

Monograph alcohols (topical) anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal

April 7, 2010

Sub-category analgesic, anesthetic, antipruritic analgesic, anesthetic, antipruritic analgesic, anesthetic, antipruritic anesthetic anesthetic anticholinergic anticholinergic antiseptic antiseptic antiseptic antiseptic antiseptic antiseptic astringent astringent astringent astringent counterirritant counterirritant counterirritant counterirritant keratolytic keratolytic keratolytic keratolytic local anesthetic local anesthetic local anesthetic local anesthetic local anesthetic local anesthetic local anesthetic local anesthetic local anesthetic other other other other other other

Panel I III(e,i)

Pending I I(e) I(e) I(e)

II(e,i) II(e,i) II(e,i) II(e,i) II(e,i) II(e,i) II(e,i) III(e),II(i) II(e,i) I(e,i) II(e,i) I(e) I(e,i) II(e,i) II(e,i) II(e,i) II(e,i) I(e) III(e),II(i) I(e),II(i) III(e),II(i) I(e),III(i) I(e),III(i) I(e),III(i) I(e),III(i) I III(e,i) I(e),III(i) I(e),III(i) I(e),III(i) III(e,i) I(e),III(i) III(e,i) I(e),III(i) II(e,i) II(e,i) II(e,i) II(e,i)

II(e,i) II(e,i)

II(e,i)

Final 346.16(a) 346.16(b) 346.16(c) 310.545(a)(26)(vi) 310.545(a)(26)(vi) 310.545(a)(26)(i) 310.545(a)(26)(i) 310.545(a)(26)(ii) 310.545(a)(26)(ii) 310.545(a)(26)(ii) 310.545(a)(26)(ii) 310.545(a)(26)(ii) 310.545(a)(26)(ii) 346.18(a) 310.545(a)(26)(iii) 346.18(b) 346.18(c) 310.545(a)(26)(iv) 310.545(a)(26)(iv) 310.545(a)(26)(iv) 310.545(a)(26)(iv) 346.20(a) 310.545(a)(26)(v) 346.20(b) 310.545(a)(26)(v) 346.10(a) 346.10(b) 346.10(c) 346.10(d) 346.10(e) 346.10(f) 346.10(g) 346.10(h) 346.10(i) 310.545(a)(26)(vii) 310.545(a)(26)(vii) 310.545(a)(26)(vii) 310.545(a)(26)(vii) 310.545(a)(26)(vii) 310.545(a)(26)(vii)

FR Citation

OTC Active Ingredients

UNII Code 5QB0T2IUN0 A6I4E79QF1 M41L2IN55T YIW503MI7V YIW503MI7V 5120YT1CRR BBL281NWFG PDC6A3C0OX 8334LX7S21 24H4NWX5C0 7EV65EAW6H T5L8T28FGP 4T6H12BN9U 4B24275HEU 08232NY3SJ 4T6H12BN9U SOI2LOH54Z U6X61U5ZEG YKH834O4BH WBB047OO38 04JA59TNSJ 1C6V77QF41 BBL281NWFG 3NY3SM6B8U 367E55FXGW 4B24275HEU 81G40H8B0T WI4X0X7BPJ 88AYB867L5 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 F92V3S5210 F92V3S5210

Active Ingredient aluminum hydroxide gel bismuth oxide bismuth subcarbonate bismuth subgallate bismuth subnitrate calamine (in combination only) cocoa butter cod liver oil (in combination only) glycerin hard fat kaolin lanolin lanolin alcohols mineral oil petrolatum shark liver oil (combination only) topical starch white petrolatum zinc oxide (combination only) ephedrine sulfate epinephrine epinephrine hydrochloride epinephrine undecylenate phenylephrine hydrochloride cholecalciferol (vitamin D) cod liver oil live yeast cell derivative Peruvian balsam shark liver oil vitamin A hydrocortisone (combination) pramoxine hydrochloride (combination) aluminum carbonate gel (basic) aluminum hydroxide aluminum hydroxide-hexitol, stabilized polymer aluminum hydroxide-magnesium carbonate, co-dried gel aluminum hydroxide-magnesium trisilicate, co-dried gel aluminum hydroxide-sucrose powder hydrated aluminum phosphate aluminum phosphate gel (in combination only) bicarbonate

Monograph anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal anorectal antacid antacid antacid antacid antacid antacid antacid antacid antacid

Sub-category protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant protectant vasoconstrictor vasoconstrictor vasoconstrictor vasoconstrictor vasoconstrictor wound healing wound healing wound healing wound healing wound healing wound healing

April 7, 2010

Panel I(e,i) III(e,i) III(e,i) III(e,i) II(e,i) I(e,i) I(e,i) I(e,i) I(e)

Pending I(e,i) III(e,i) III(e,i) III(e,i) II(e,i) I(e,i) I(e,i) I(e,i) I(e)

I(e,i) I(e,i) I(e,i) I(e,i)

I(e,i) I(e,i) III(e,i) I(e,i) I(e,i) I(e,i) I(e,i) I(e,i) I(e,i) I I(e),III(i) I(e),II(i) I I III(e,i) III(e,i) III(e,i) III(e,i) III(e,i) III(e,i)

I(e,i) I(e,i) I(e,i) I(e,i) I III(e,i) I(e),II(i) I III(e,i) III(e,i) III(e,i) III(e,i) III(e,i) III(e,i)

I I I I I I I I

Final 346.14(a)(1) 310.545(a)(26)(viii) 310.545(a)(26)(viii) 310.545(a)(26)(viii) 310.545(a)(26)(viii) 346.14(b)(1) 346.14(a)(2) 346.14(b)(2) 346.14(a)(3) 346.14(a)(4) 346.14(a)(5) 346.14(a)(6) 310.545(a)(26)(viii) 346.14(a)(7) 346.14(a)(8) 346.14(b)(3) 346.14(a)(9) 346.14(a)(10) 346.14(b)(4) 346.12(a) 346.12(b) 346.12(c) 310.545(a)(26)(ix) 346.12(d) 310.545(a)(26)(x) 310.545(a)(26)(x) 310.545(a)(26)(x) 310.545(a)(26)(x) 310.545(a)(26)(x) 310.545(a)(26)(x) 310.545(a)(26)(xi) 310.545(a)(26)(xi) 331.11(a)(1) 331.11(a)(2) 331.11(a)(2) 331.11(a)(2) 331.11(a)(2) 331.11(a)(2) 331.11(i)(1) 331.11(a)(4) 331.11(b)

FR Citation

OTC Active Ingredients

UNII Code JB5Y63JDHJ M41L2IN55T M41L2IN55T YIW503MI7V YIW503MI7V SY7Q814VUP H0G9379FGK H0G9379FGK 2P3VWU3H10 D0250MG0W6 D0250MG0W6 84H8Z9550J TE7660XO1C

6M2P64V0NC 6M2P64V0NC 0E53J927NA IFN18A4Y6B NBZ3QY004S 3A3U0GI71G C2E1CI501T C2E1CI501T 917J3173FT HM5Z15LEBN BQN1B9B9HA 8MDF5V39QO 45P3261C7T QH257BPV3J QH257BPV3J K4C08XP666 J4Z741D6O5 63KP7FXF2I 81BK194Z5M 8ZYQ1474W7 8ZYQ1474W7 C810JCZ56Q C810JCZ56Q 3FTR44B32Q

Active Ingredient Monograph bismuth aluminate antacid bismuth carbonate antacid bismuth subcarbonate antacid bismuth subgallate antacid bismuth subnitrate antacid calcium (mono or dibasic salt) antacid calcium carbonate antacid calcium phosphate antacid Charcoal, activated antacid citrate (containing active ingredients: citrate ion, as citric acid or salt) antacid dihydroxyaluminum aminoacetate antacid dihydroxyaluminum aminoacetic acid antacid dihydroxyaluminum sodium carbonate antacid glycine (aminoacetic acid) antacid hydrate magnesium aluminate activated sulfate antacid magaldrate antacid magnesium aluminosilicate antacid magnesium aluminosilicate antacid magnesium carbonate antacid magnesium glycinate antacid magnesium hydroxide antacid magnesium oxide antacid magnesium trisilicate antacid magnesium trisilicate antacid milk solids, dried antacid potassium bicarbonate antacid potassium carbonate antacid sodium bicarbonate antacid sodium carbonate antacid sodium potassium tartrate antacid sodium potassium tartrate antacid tartrate (acid or salt) antacid tricalcium phosphate antacid gentian voilet anthelmintic piperazine citrate anthelmintic pyrantel pamoate anthelmintic sodium fluoride gel or paste anticaries sodium fluoride powder anticaries sodium monolfuorophosphate (gel or paste) anticaries sodium monolfuorophosphate (gel or paste) anticaries stannous fluoride anticaries

April 7, 2010

Sub-category

Panel

Pending I I I I I I I IIIE I I I I I I I I I I I I I I

I I I I I

dentifrices dentifrices dentifrices dentifrices dentifrices

I II I I I I I

II IIS I I I I I I

Final 331.11(c)(1) 331.11(c)(2) 331.11(c)(3) 331.11(c)(4) 331.11(c)(5) 331.11(i)(2) 331.11(d) 331.11(d)

FR Citation

331.11(e) 331.11(a)(3) 331.11(a)(3) 331.11(a)(5) 331.11(f) 331.11(g)(1) 331.11(g)(2) 331.11(g)(3) 331.11(l)(1) 331.11(g)(4) 331.11(g)(5) 331.11(g)(6) 331.11(g)(7) 331.11(g)(8) 331.11(l)(2) 331.11(h) 331.11(j)(1) 331.11(j)(1) 331.11(k)(1) 331.11(k)(1) 331.11(j)(2) 331.11(k)(2) 331.11(m) 331.11(i)(3) [51 FR 27758] 357.11 355.10(a)(1) 355.10(a)(2) 355.10(b)(1) 355.10(b)(2) 355.10(c)(1)(i)

OTC Active Ingredients

UNII Code 3FTR44B32Q

O7TSZ97GEP RGL5YE86CZ E4GA8884NN 8MDF5V39QO 45P3261C7T 3980JIH2SW 8ZYQ1474W7 8ZYQ1474W7 8ZYQ1474W7 C810JCZ56Q C810JCZ56Q SE337SVY37 SE337SVY37 3FTR44B32Q 3FTR44B32Q U6V729APAM YIW503MI7V PF5DZW74VN 2P3VWU3H10 89NA02M4RX BQN1B9B9HA G280W4MW6E LMI26O6933 5QB0T2IUN0 03J5ZE7KA5 62TEY51RR1 H0G9379FGK K679OBS311 TE7660XO1C 68JRS2HC1C F2R8V82B84 24H4NWX5C0

Active Ingredient Monograph stannous fluoride anticaries acidulated phosphate fluoride anticaries acidulated phosphate fluoride anticaries calcium sucrose phosphate anticaries dicalcium phosphate dihydrate anticaries disodium hydrogen phosphate anticaries hydrogen fluoride anticaries phosphoric acid anticaries sodium bicarbonate anticaries sodium carbonate anticaries sodium dihydrogen phosphate anticaries sodium dihydrogen phosphate monohydrate anticaries sodium fluoride (aqueous) anticaries sodium fluoride (aqueous) (acidulated phosphate fluoride with .01% fl anticaries sodium fluoride (aqueous) (acidulated phosphate fluoride with .02% fl anticaries sodium monofluorophosphate anticaries sodium monofluorophosphate (rinse) anticaries sodium phosphate anticaries sodium phosphate anticaries stannous fluoride (gel) anticaries stannous fluoride (rinse) anticaries attapulgite, activated antidiarrheal bismuth subnitrate antidiarrheal calcium hydroxide antidiarrheal calcium polycarbophil antidiarrheal charcoal (activated) antidiarrheal pectin antidiarrheal polycarbophil antidiarrheal potassium carbonate antidiarrheal rhubarb fluidextract antidiarrheal alumina powder, hydrated antidiarrheal aluminum hydroxide antidiarrheal atropine sulfate antidiarrheal bismuth subsalicylate antidiarrheal calcium carbonate precipitated antidiarrheal carboxymethylcellulose sodium antidiarrheal glycine antidiarrheal homatropine methylbromide antidiarrheal antidiarrheal hyocyamine sulfate kaolin antidiarrheal Lactobacillus acidophilis antidiarrheal

April 7, 2010

Sub-category dentifrices

Panel I

II II II NC II II

Pending I I I NC NC NC III NC II

II II I/NC NC I

NC NC I I I

II II II I I III III III NC III III I II II III

II NC NC I I I III III I III III I II II III

III III III

III IIIE III

II III III III III

II III III IIIE III

Final 355.10(c)(1)(ii) 355.10(a)(3)(i) 355.10(a)(3)(ii) 310.545(a)(2)(ii) 310.545(a)(2)(ii) 310.545(a)(2)(ii) 310.545(a)(2)(i) 310.545(a)(2)(ii) 310.545(a)(2)(i) 310.545(a)(2)(ii) 310.545(a)(2)(ii) 355.10(a)(3)(iii)-(v)

310.545(a)(2)(i)

w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000

310.545(a)(2)(i) 310.545(a)(2)(ii) 355.10(c)(2) 355.10(c)(3) 310.545(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(ii) 310.545(a)(3)(i) 310.545(a)(3)(i) 335.10(a) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 335.10(b) 310.545(a)(3)(i)

FR Citation

OTC Active Ingredients

UNII Code

28A37T47QO 451IFR0GXB 4O71YT5YB5 TE7660XO1C 62TEY51RR2 W0O1NHP4WE JB937PER5C TC2D6JAD40 HDP7W44CIO 28A37T47QO 451IFR0GXB 4O71YT5YB5 TYU5GP6XGE 18B8O9DQA2 1L24V9R23S 34S289N54E 5P5C03819W PH41D05744 8SKN0B0MIM GRE0P19C3Z R57ZHV85D6 77YW1RTU8V 5TJD82A1ET

LJ25TI0CVT LJ25TI0CVT 7BHQ856EJ5 7BHQ856EJ5 G07GZ97H65 R533ESO2EC 789U1901C5 T1J0JOU64O AIU7053OWL

Active Ingredient Lactobacillus bulgaricus Opium powder Opium tincture paregoric phenyl salicylate (salo) scopolamine hydrobromide sodium carboxymethylcellulose zinc phenolsulfonate aminoacetic acid bismuth subsalicylate cyclizine hydrochloride dimenhydrinate diphenhydramine hydrochloride meclizine hydrochloride phenyl salicylate phosphorated carbohydrate soopolamine hydrobromide zinc phenolsulfonate simethicone alcloxa alum, potassium aluminum sulfate amyltricresols, secondary basic fuchsin benzethonium chloride benzoic acid benzoxiquine boric acid calcium undecylenate camphor camphorated metacresol candicidin chlorothymol chloroxylenol clioquinol clioquinol (lodochlorhydroxyquin) clotrimazole coal tar copper undecylenate dichlorophen haloprogin

Monograph antidiarrheal antidiarrheal antidiarrheal antidiarrheal antidiarrheal antidiarrheal antidiarrheal antidiarrheal antiemetic antiemetic antiemetic antiemetic antiemetic antiemetic antiemetic antiemetic antiemetic antiemetic antiflatulent antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal antifungal

April 7, 2010

Sub-category

Panel III I I I III II III III

III III

Pending III III III III III II III III II III I I IIIE I II III III II I III III

III III

III III III I II III II III III I I

III III

II I III I

I II III II III III I I I II I III I

Final 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(3)(i)

336.10(a) 336.10(b) 336.10(c) 336.10(d)

332.10 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 333.210(f) 310.545(a)(22)(ii) 310.545(a)(22)(iv) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(iv) 333.210(a) 333.210(a) 333.210(g) 310.545(a)(22)(ii) 333.210(f) 310.545(a)(22)(ii) 333.210(b)

FR Citation

OTC Active Ingredients

UNII Code GGO4Y809LO L7T10EIP3A A2I8C7HI9T VW4H1CYW1K BDF1O1C72E 5UTX5635HP 61VUG75Y3P 339NCG44TV 4NC0T56V35 28A37T47QO 85H0HZU99M JHU490RVYR Z8IX2SC1OH YUL4LO94HK O414PZ4LPZ 91MBZ8H3QO 9XTM81VK2B DK6Y9P42IN 70FD1KFU70 28F9E0DJY7 3J50XA376E 5236RK32KG 06KB629TKV XHX3C3X673 K3D86KJ24N QL5435GI2S 388VZ25DUR A7V27PHC7A 3JJ4O33LAY JD546Z56F0 J2D46N657D M0T18YH28D 53GH7MZT1R IY191986AO

FXS1BY2PGL

Active Ingredient Monograph m-cresol antifungal menthol antifungal methylparaben antifungal miconazole nitrate antifungal nystatin antifungal oxyquinoline antifungal oxyquinoline sulfate antifungal phenol antifungal phenolate sodium antifungal antifungal phenyl salicylate povidone-iodine antifungal propionic acid antifungal propylparaben antifungal resorcinol antifungal salicylic acid antifungal sodium borate antifungal sodium caprylate antifungal sodium propionate antifungal sulfur antifungal tannic acid antifungal thymol antifungal tolindate antifungal tolnaftate antifungal triacetin antifungal undecylenic acid antifungal zinc caprylate antifungal zinc propionate antifungal zinc undecylenate antifungal quinine antimalarial mercury-containing ingredient antimicrobial para-chloromercuriphenol antimicrobial ammoniated mercury antimicrobial calomel (mercurous chloride) antimicrobial merbromin (mercurochrome) antimicrobial mercufenol chloride (orthochloromercuriphenol, orthohydroxyphenyl antimicrobial mercuric chloride (bichloride of mercury, mercury chloride) antimicrobial mercuric oxide, yellow antimicrobial mercuric salicylate antimicrobial mercuric sulfide, red antimicrobial antimicrobial mercury mercury oleate antimicrobial

April 7, 2010

Sub-category

diaper rash diaper rash first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic

Panel

Pending

II III I I III III II II III III III III II III III III III III II II II I III I III III I

II III I III III III III III III I III III II III III III

II I III I III III I

Final 310.545(a)(22)(iv) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 333.210(c) 310.545(a)(22)(iv) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 333.210(d) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 333.210(e) 310.545(a)(22)(ii) 333.210(f) 310.545(a)(22)(ii) 310.545(a)(22)(ii) 333.210(f) 310.547 310.545(a)(27)(ii) 310.545(a)(27)(ii) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i)

FR Citation

OTC Active Ingredients

UNII Code RU6242GP15 3JJ4O33LAY CG8692ZN14 2225PI3MOV

F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 62TEY51RR3 77YW1RTU8V LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G

Active Ingredient mercury sulfide nitromersol para-chloromercuriphenol phenylmercuric nitrate thimerosal vitromersol zyloxin benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzethonium chloride benzethonium chloride benzethonium chloride benzethonium chloride benzethonium chloride benzethonium chloride benzethonium chloride bismuth subsalicylate calcium undecylenate chloroxlyneol chloroxlyneol chloroxlyneol chloroxlyneol chloroxlyneol chloroxlyneol chloroxlyneol chloroxlyneol chloroxlyneol cloflucarban cloflucarban cloflucarban cloflucarban cloflucarban cloflucarban cloflucarban cloflucarban

Monograph antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial

Sub-category first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic first aid antiseptic

April 7, 2010

Panel

Pending

I I IIISE IIISE IIISE IIISE IIISE IISE I IIIE IIISE IIISE IIISE IIISE IISE IISE IIISE IIIE IIIE IIISE IIISE IIISE IIISE IIISE IIISE IIISE IIIS IIISE IIISE IISE IISE IISE IISE IISE

Final 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i)

FR Citation

OTC Active Ingredients

UNII Code 80OFG3WPYD IWW5FV6NK2 R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N BBX060AN9V

9679TC07X10 9679TC07X11 9679TC07X4 9679TC07X5 9679TC07X6 9679TC07X7 9679TC07X8 9679TC07X9 9679TC07X4

Active Ingredient fluorosalan hexachlorophene hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hydrogen peroxide iodine complex/phosphate ester of alkylaryloxy polyethylene iodine complex/phosphate ester of alkylaryloxy polyethylene iodine complex/phosphate ester of alkylaryloxy polyethylene iodine complex/phosphate ester of alkylaryloxy polyethylene iodine complex/phosphate ester of alkylaryloxy polyethylene iodine complex/phosphate ester of alkylaryloxy polyethylene iodine complex/phosphate ester of alkylaryloxy polyethylene iodine tincture iodine tincture iodine tincture iodine tincture iodine tincture iodine tincture iodine tincture iodine tincture iodine topical solution methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine

April 7, 2010

Sub-category

Panel

Pending IIS

Final

FR Citation [37 FR 20163]

I I IIE IIIE IIIE IIIE IIIE IIIE I IIISE IIISE IIISE IIISE IIISE IIISE IISE IISE IISE I I IIIS IIIS IIISE IIS I I I IIIE IIISE IIISE IIISE IIISE IISE IIISE IIISE IIISE IIISE IIISE IISE

OTC Active Ingredients

UNII Code 5UTX5635HP 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV LQA7B6G8JG

85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M YUL4LO94HK 4B24275HEU DK6Y9P42IN BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y

Active Ingredient oxyquinoline phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol poloxamer 188 poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine resorcinol shark liver oil sodium propionate triclocarban triclocarban triclocarban triclocarban triclocarban

April 7, 2010

Sub-category

Panel

Pending IIISE I IIIE IIIE IIIE IIIE IIIE IIIE IIIE IIISE IIS IIS IIS IIS IIS IIS IIS I IIISE IIISE IIISE IIISE IIISE IIISE IISE I IIISE IIISE IIISE IIISE IIISE IIISE IIISE IISE n/a IIISE IIIE IIISE IIISE IIISE IISE

Final

FR Citation

OTC Active Ingredients

UNII Code BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X

1L24V9R23S LIF1N9568Y LIF1N9568Y LIF1N9568Y HPN8MZW13M

UCN889409V

Active Ingredient triclocarban triclocarban triclocarban triclosan triclosan triclosan triclosan triclosan triclosan triclosan triclosan triclosan triple dye triple dye triple dye triple dye triple dye triple dye triple dye triple dye undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex aluminum sulfate buffered w/ sodium aluminum lactate alum, potassium aluminum bromohydrate aluminum chloride (alcoholic solutions) aluminum chloride (aqueous solution) (aerosol only) aluminum chloride (nonaerosol aqueous solution) aluminum chlorohydrate aluminum chlorohydrex polyethylene glycol aluminum chlorohydrex propylene glycol aluminum dichlorohydrate aluminum dichlorohydrex polyethylene glycol aluminum dichlorohydrex propylene glycol aluminum sesquichlorohydrate aluminum sesquichlorohydrate poylethylene glycol

Monograph antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant

April 7, 2010

Sub-category

Panel

w/ sales less than $25,000

I IIISE IISE IIS

Pending IISE IISE IISE IIIE IIISE IIISE IIISE IIISE IIISE IIISE IIISE IIISE IIISE IIISE IIISE IISE IISE IISE IISE IISE IIIE IIISE IIISE IIISE IIISE IIISE IISE IIIS IIISE IISE IIS

I I I I I I I I I

Final

310.545(a)(4)(ii) 310.545(a)(4)(i) 310.545(a)(4)(i) 310.545(a)(4)(i) 310.545(a)(4)(i) 350.10(a) 350.10(b) 350.10(c) 350.10(d) 350.10(e) 350.10(f) 350.10(g) 350.10(h) 350.10(i)

FR Citation

OTC Active Ingredients

UNII Code 34S289N54E 481Y8HDW2B P9D3YP29MY 15K31617MU 94703016SM 8O386558JE 8O386558JE T27D6T99LH T27D6T99LH OR5RM3Q5QL 241ATL177A O414PZ4LPZ O414PZ4LPZ Q40Q9N063P 344S277G0Z PQ6CK8PD0R WQZ3G9PF0H HM4YQM8WRC 5YZ5R8I73Y 9679TC07X4 LAV5U5022Y WV9CM0O67Z YRC253429Q 28A37T47QO 81G40H8B0T 86Q357L16B WQZ3G9PF0H 03J5ZE7KA5 WQZ3G9PF0H IXA7C9ZN03 NPB7A7874U V1Q0O9OJ9Z BPA9UT29BS B10YD955QW

Active Ingredient aluminum sesquichlorohydrate propylene glycol aluminum sulfate aluminum sulfate, buffered (aerosol only) aluminum zirconium octachlorohydrate aluminum zirconium octachlorohydrex gly aluminum zirconium pentachlorohydrate aluminum zirconium pentachlorohydrex gly aluminum zirconium tetrachlorohydrate aluminum zirconium tetrachlorohydrex gly aluminum zirconium trichlorohydrate aluminum zirconium trichlorohydrex gly sodium aluminum chlorohydroxy lactate aminacrine hydrochloride corn oil, aqueous emulsion soybean oil, hydrogenated (powder) salicylic acid salicylic acid acetic acid, glacial allantoin (5-ureidohydantoin) ascorbic acid belladonna alkaloids chlorobutanol diperodon hydrochloride ichthammol iodine methyl salicylate methylbenzethonium chloride panthenol phenoxyacetic acid phenyl salicyiate vitamin A zinc chloride atropa belladonna atropine sulfate belladonna alkaloids datura stramonium brompheniramine maleate chlorcyclizine hydrochloride chlorpheniramine maleate dexbromopheniramine maleate dexchlorpheniramine maleate

Monograph Sub-category antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant boil treatment cholecystokinetic cholecystokinetic corn/callus remover collodoin-like vehicle corn/callus remover plaster vehicle corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover corn/callus remover cough/cold anticholinergic cough/cold anticholinergic cough/cold anticholinergic cough/cold anticholinergic cough/cold antihistamine cough/cold antihistamine cough/cold antihistamine cough/cold antihistamine cough/cold antihistamine

April 7, 2010

Panel I IIISE I I I I I I I I I IIISE

Pending I IIISE IIIS IIS IIS IIS IIS IIS IIS IIS IIS IIISE IISE I

I I II II II II II II II II II II II III II II III

I I IIISE IISE IISE IISE IISE IISE IISE IISE IISE IISE IISE IIIE II IISE IIIE II III IIIE II I I I I I

I I

Final 350.10(j) 310.545(a)(4)(i) 310.545(a)(4)(i) 350.10(k) 350.10(l) 350.10(m) 350.10(n) 350.10(o) 350.10(p) 350.10(q) 350.10(r) 310.545(a)(4)(i) 310.531(a) 357.210(a) 357.210(b) 358.510(b) 358.510(a)

FR Citation

[55 FR 33254] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] [55 FR 33261] 310.53 310.53 310.53 310.53 341.12(a) 341.12(b) 341.12(c) 341.12(d) 341.12(e)

OTC Active Ingredients

UNII Code 8GTS82S83M TC2D6JAD41 V9BI9B5YI2 LT10EIP3A GJ20H50YF0 KJ5I25TXYL 00S42N58OM V95R5KMY2B 28725X3PV8 NYW905655B 8UE48MJH8M R35D29L3ZA 7ZQC1892H9 6K9YKD48Y4 YAN7R5L890 5P4DHS6ENR 5TJD82A1ET 5TJD82A1ET 09TQU5PG95 4SH0MFJ5HJ 69QQ58998Y BBL281NWFG Q830PW7520 GSL05Y1MN6 11QV9BS0CB 7355X3ROTS 9D2RTI9KYH 8GTS82S83M TC2D6JAD42 91QY4PXU8Q MFM5450P3T RV6J6604TK RV6J6604TK 2R04ONI663 2R04ONI664 2R04ONI665 7A72MUN24Z NO70W886KK LT10EIP3A

Active Ingredient diphenhydramine citrate diphenhydramine hydrochloride doxylamine succinate menthol (mouthwash) metaproterenol sulfate methapyrilene fumarate methapyrilene hydrochloride peppermint oil (mouthwash) phenindamine tartrate pheniramine maleate phenyltoloxamine dihydrogen citrate phenyltoloxamine hydrochloride pyrilamine maleate thenyldiamine hydrochloride thonzylamine hydrochloride triprolidine hydrochloride benzonatate camphor camphor caramiphen edisylate carbetapentane citrate chlophedianol hydrochloride cod liver oil codeine codeine phosphate codeine sulfate creosote, beechwood dextromethorphan dextromethorphan hydrobromide diphenhydramine citrate diphenhydramine hydrochloride elm bark ethylmorphine hydrochloride eucalyptol eucalyptol eucalyptus oil eucalyptus oil eucalyptus oil horehound hydrocodone bitartrate menthol

Monograph cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold

Sub-category antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive

April 7, 2010

Panel

Pending

I I III I II II

III I I I I

I I

I III I

I III I I I IIIE I IIIE IIIE I IIIE I I I IIIE I I

III III III III III I I I III I I III III III

III III III III II

IIIE IIIE IIIE IIIE IIIE IIIE IIIE IIIE IIIE IIS IIIE

Final 341.12(f) 341.12(g) 341.12(h) 310.545(a)(6)(ii)(A) 310.545(a)(6)(iv) 310.545(a)(6)(i) 310.545(a)(6)(i) 310.545(a)(6)(ii)(A) 341.12(i) 341.12(j) 310.545(a)(6)(i) 310.545(a)(6)(i) 341.12(k) 310.545(a)(6)(i) 341.12(l) 341.12(m)

FR Citation

341.14(b)(1) 341.14(b)(1)

steam inhalation topical [52 FR 30054] [52 FR 30054] oral [52 FR 30054] oral oral oral [52 FR 30054] oral oral oral oral [52 FR 30054] [52 FR 30054] [52 FR 30055] [52 FR 30055] [52 FR 30055] [52 FR 30054] [52 FR 30055] [52 FR 30054] [52 FR 30054] steam inhalation

341.14(a)(1) 341.14(a)(2)(i) 341.14(a)(2)(ii) 341.14(a)(2)(iii) 341.14(a)(3) 341.14(a)(4) 341.14(a)(5) 341.14(a)(6)

341.14(b)(2)

OTC Active Ingredients

UNII Code LT10EIP3A LT10EIP3A LT10EIP3A

V95R5KMY2B XJ6RUH0O4G XJ6RUH0O4G 27Y3KJK423 WQZ3G9PF0H GN83C131XS NLJ6390P1Z U6X61U5ZEG YKH834O4BH YKH834O4BH 30Q7KI53AK 30Q7KI53AK WBB047OO38 L13YF113GN 52V8BVV7FX 6V9V2RYJ8N Y9DL7QPE6B 43SK4LAO7D 43SK4LAO7D 43SK4LAO7D C137DTR5RG

0I55128JYK R0JB3224WS DL6OZ476V3 L7J6A1NE81 5TJD82A1ET 7V31YC746X 2R04ONI662 495W7451VQ 7A72MUN24Z 62I3C8233L 62I3C8233L

Active Ingredient Monograph menthol cough/cold menthol cough/cold menthol cough/cold noscapine cough/cold noscapine hydrochloride cough/cold peppermint oil cough/cold turpentine oil (oral) cough/cold turpentine oil (topical/inhalant) cough/cold aminophylline cough/cold belladonna alkaloids cough/cold ephedrine cough/cold ephedrine hydrochloride cough/cold ephedrine sulfate cough/cold epinephrine cough/cold epinephrine cough/cold epinephrine bitartrate cough/cold epinephrine bitartrate cough/cold epinephrine hydrochloride cough/cold cough/cold euphorbia pilulifera methoxyphenamine hydrochloride cough/cold pseudoephedrine hydrochloride cough/cold pseudoephedrine sulfate cough/cold racephedrine hydrochloride cough/cold racepinephrine hydrochloride cough/cold racepinephrine hydrochloride cough/cold theophylline (in combination) cough/cold theophylline calcium salicylate cough/cold theophylline sodium glycinate cough/cold cough/cold theophylline, anhydrous ammonium chloride cough/cold antimony potassium tartrate cough/cold beachwood creosote cough/cold benzoin preparations (compound tincture of benzoin, tincture of benz cough/cold camphor cough/cold chloroform cough/cold eucalyptol/eucalyptus oil cough/cold guaifenesin cough/cold horehound cough/cold iodides (calcium iodide anyhydrous, hydroidic acid syrup, iodized lim cough/cold ipecac cough/cold ipecac fluidextract cough/cold

Sub-category antitussive antitussive antitussive antitussive antitussive antitussive antitussive antitussive bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator bronchodilator expectorant expectorant expectorant expectorant expectorant expectorant expectorant expectorant expectorant expectorant expectorant expectorant

April 7, 2010

Panel III III III III III III III I II I I I I I I I I III I II II I I I I I

Pending IIIE I I IIIE IIIE IIIE IISE IIIE II II I I I I I I I I III II II II I I I II II II III II III III III II III IIIE II II

Final 341.14(b)(2) 341.14(b)(2) 341.14(b)(2)

FR Citation lozenge lozenge topical [52 FR 30054] [52 FR 30054] [52 FR 30054] [52 FR 30055]

310.545(a)(6)(iv) 310.545(a)(6)(iv) 341.16(a) 341.16(b) 341.16(c) 341.16(d) 341.16(d) 341.16(e) 341.16(e) 310.545(a)(6)(iv) 310.545(a)(6)(iv) 310.545(a)(6)(iv) 310.545(a)(6)(iv) 341.16(f) 341.16(g) 341.16(g) 310.545(a)(6)(iv)(B) 310.545(a)(6)(iv) 310.545(a)(6)(iv) 310.545(a)(6)(iv) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 341.18 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii)

inhalation rubber bulb inhalation rubber bulb

inhalation rubber bulb

topical/inhalant

OTC Active Ingredients

UNII Code 62I3C8233L

TTK33Z47F1 1Q73Q2JULR 3629601H5D TD2LE91MBE XJ6RUH0O4G 3G6A5W338E YQE403BP4D BN34FX42G3 5TJD82A1ET 5TJD82A1ET BJ169U4NLG

GN83C131XS GN83C131XS GN83C131XS NLJ6390P1Z NLJ6390P1Z NLJ6390P1Z U6X61U5ZEG U6X61U5ZEG U6X61U5ZEG RV6J6604TK RV6J6604TK 2R04ONI666 2R04ONI672 2R04ONI673 Y24T9BT2Q2 Y24T9BT2Q2 LT10EIP3A N4G8379626 MZ1131787D MZ1131787D MZ1131787D MZ1131787D K89MJ0S5VY

Active Ingredient Monograph ipecac syrup cough/cold menthol/peppermint oil cough/cold pine tar preparations (extract white pine compound, pine tar, syrup of cough/cold potassium guaiacolsulfonate cough/cold sodium citrate cough/cold squill preparations (squill, squill extract) cough/cold terpin hydrate prearations (terpin hydrate, terpin hydrate elixer) cough/cold tolu preparations (tolu, tolu balsalm, tolu balsalm tincture) cough/cold turpentine oil (spirits of turpentine) cough/cold caffeine cough/cold phenobarbital cough/cold cough/cold allyl isothiocyanate bornyl acetate (topical) cough/cold camphor cough/cold camphor (lozenge) cough/cold cedar leaf oil (topical) cough/cold creosote, beechwood (oral) cough/cold creosote, beechwood (topical) cough/cold ephedrine (aqueous) cough/cold ephedrine (jelly) cough/cold ephedrine (oral) cough/cold ephedrine hydrochloride (aqueous) cough/cold ephedrine hydrochloride (jelly) cough/cold ephedrine hydrochloride (oral) cough/cold ephedrine sulfate (aqueous) cough/cold ephedrine sulfate (jelly) cough/cold ephedrine sulfate (oral) cough/cold eucalyptol (lozenge) cough/cold eucalyptol (mouthwash) cough/cold eucalyptus oil cough/cold eucalyptus oil (lozenge) cough/cold eucalyptus oil (mouthwash) cough/cold levmetamfetamine cough/cold levmetamfetamine cough/cold menthol cough/cold mustard oil (alltlishthiocyanate) (tpoical/inhalant) cough/cold naphazoline hydrochloride cough/cold naphazoline hydrochloride cough/cold naphazoline hydrochloride (jelly) cough/cold naphazoline hydrochloride (jelly) cough/cold oxymetazoline hydrochloride (aqueous) cough/cold

Sub-category expectorant expectorant expectorant expectorant expectorant expectorant expectorant expectorant expectorant miscellaneous miscellaneous nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant

April 7, 2010

Panel

Pending III III III III III II III III

Final 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(6)(iii)

FR Citation

IIIE IIS III III III III III III I III I III I III III III III III III

III II

I I

III IIIE III III III III I I III I I III I I III III III IIIE III III I I IIIE II I I I I I

310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(B) [59 FR 43408] 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(B) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(B) 341.20(b)(2) 341.20(b)(2) 310.545(a)(6)(ii)(B) 341.20(b)(3) 341.20(b)(3) 310.545(a)(6)(ii)(B) 341.20(b)(4) 341.20(b)(4) 310.545(a)(6)(ii)(B) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) [59 FR 43408] 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) 341.20(b)(1) 341.20(b)(1)

341.20(b)(6) 341.20(b)(6) 341.20(b)(6) 341.20(b)(6) 341.20(b)(7)

inhalant topical [59 FR 43408]

OTC Active Ingredients

UNII Code K89MJ0S5VY K89MJ0S5VY V95R5KMY2B V95R5KMY2B V95R5KMY2B 27O3Q5ML57 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ B48FTC099P 8D5I63UE1Q 8D5I63UE1Q LQU92IU8LL 6V9V2RYJ8N Y9DL7QPE6B Y9DL7QPE6B 43SK4LAO7D 7ZQC1892H9 7ZQC1892H9 3J50XA376E 3J50XA376E 3J50XA376E XJ6RUH0O4G XJ6RUH0O4G X5S84033NZ X5S84033NZ X5S84033NZ X5S84033NZ O414PZ4LPZ Z69D9E381Q Z69D9E381Q 70FD1KFU70 R953O2RHZ6 R953O2RHZ5 R533ESO2EC

Active Ingredient oxymetazoline hydrochloride (aqueous) oxymetazoline hydrochloride (jelly) peppermint oil peppermint oil peppermint oil phenylephrine bitartrate (effervescent) phenylephrine hydrochloride phenylephrine hydrochloride (aqueous) phenylephrine hydrochloride (aqueous) phenylephrine hydrochloride (aqueous) phenylephrine hydrochloride (aqueous) phenylephrine hydrochloride (jelly) phenylephrine hydrochloride (jelly) phenylephrine hydrochloride (jelly) phenylpropanolamine bitartrate phenylpropanolamine hydrochloride (oral) phenylpropanolamine hydrochloride (topical) phenylpropanolamine maleate propylhexedrine pseudoephedrine hydrochloride pseudoephedrine sulfate pseudoephedrine sulfate (oral) racephedrine hydrochloride (oral/topical) thenyldiamine hydrochloride thenyldiamine hydrochloride thymol thymol (lozenge) thymol (mouthwash) turpentine oil (spirits of turpentine) (oral) turpentine oil (spirits of turpentine) (topical) xylometazoline hydrochloride (aqueous) xylometazoline hydrochloride (aqueous) xylometazoline hydrochloride (jelly) xylometazoline hydrochloride (jelly) salicylic acid selenium sulfide selenium sulfide, micronized sulfur pyrithione zinc pyrithione zinc coal tar

Monograph cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold cough/cold dandruff dandruff dandruff dandruff dandruff dandruff dandruff

Sub-category nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant nasal decongestant dandruff dandruff dandruff dandruff dandruff (leave-on) dandruff (wash-off) psoriasis

April 7, 2010

Panel I

I I I I I I I I I III I I I I I III III III III III II III

I I I I I I I I ISIII

Pending I I IIIE IIIE IIIE I I I I I I I I

I I I I I III IIIE III III III II III I I I I I I I I I I I

Final 341.20(b)(7) 341.20(b)(7)

FR Citation

[59 FR 43408] [59 FR 43408] [59 FR 43408] 341.20(a)(4) 341.20(a)(1) 341.20(b)(8) 341.20(b)(8) 341.20(b)(8) 341.20(b)(8) 341.20(b)(8) 341.20(b)(8) 341.20(b)(8)

341.20(b)(9) 341.20(a)(2) 341.20(a)(3)

oral

inhalant oral oral

310.545(a)(6)(ii)(B) 310.545(a)(6)(ii)(A) [59 FR 43408] 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) 341.20(b)(10) 341.20(b)(10) 341.20(b)(10) 341.20(b)(10) 358.710(a)(4) 358.710(a)(5) 358.710(a)(6) 358.710(a)(7) 358.710(a)(3) 358.710(a)(2) 358.710(c)(1)

OTC Active Ingredients

UNII Code O414PZ4LPZ R533ESO2EC O414PZ4LPZ Z69D9E381Q R953O2RHZ8 R953O2RHZ7 344S277G0Z F5UM2KM3W7 PH41D05744 U3RSY48JW7 R57ZHV85D7 77YW1RTU8V LJ25TI0CVT R533ESO2EC 8PI54V663Y 1MXY2UM8NV M9JGK7U88V RV6J6604TK

09TM5K0O34 L7T10EIP3A LAV5U5022Y 339NCG44TV 4NC0T56V35 85H0HZU99M YUL4LO94HK 91MBZ8H3QO WIQ1H85SYP 3J50XA376E K3D86KJ24N LC1V549NOM YIW503MI7V 2P3VWU3H10 9104833TPA

Active Ingredient salicylic acid coal tar salicylic acid selenium sulfide pyrithione zinc pyrithione zinc alkyl isoquinolinium bromide allantoin benzalkonium chloride benzethonium chloride benzocaine boric acid calcium undecylenate captan chloroxylenol coal tar colloidal oatmeal cresol, saponated ethohexadiol eucalyptol hydrocortisone preparations juniper tar lauryl isoquinolinium bromide menthol mercury oleate methyl salicylate methylbenzethonium chloride phenol phenolate sodium pine tar povidone-iodine resorcinol sodium borate sodium salicylate thymol undecylenic acid sodium bromide bismuth subgallate charcoal, activated chlorophyllin copper complex almadrate sulfate

Monograph Sub-category dandruff psoriasis dandruff seborrheic dermatitis dandruff seborrheic dermatitis dandruff seborrheic dermatitis dandruff seborrheic dermatitis (leave-on) dandruff seborrheic dermatitis (wash-off) dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff dandruff daytime sedative deodorants for internal use deodorants for internal use deodorants for internal use digestive aid antacid

April 7, 2010

Panel I ISIII I I I I III III III III II II

Pending I I I I I I III III III III IIE II

III III ISIII II II III III III III III III II III III III III III III II II III III III

III III I II II III III IS III III III II III III III III III III II II III III III IISE I III I I

III III III III

Final 358.710(c)(2) 358.710(b)(1) 358.710(b)(4) 358.710(b)(5) 358.710(b)(3) 358.710(b)(2) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7)

FR Citation

[56 FR 63567] 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 358.710(a)(1) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.545(a)(7) 310.519(a) 357.810(a)

56 FR 63567

[55 FR 19864] 357.810(b)

OTC Active Ingredients

UNII Code 5QB0T2IUN0 H0G9379FGK 84H8Z9550J NBZ3QY004S C2E1CI501T 8MDF5V39QO 1Q73Q2JULR TYU5GP6XGE FQ3DRG0N5K FQ3DRG0N5K 3KX376GY7L 3K9958V90M YOJ58O116E 21C2F5E8RE W9FZA51AS1 Q6Z8UK5R3G 8WB9PV3YW5 WQZ3G9PF0H 6GZW20TIOI JK8U8K4D6K M41L2IN55T YIW503MI7V 86R5J6D01D 6L5ZL09795 2C5Q57D7Z4 SQE6VB453K S07O44R1ZM S07O44R1ZM 2P3VWU3H10 483O0360NZ 7Y51EV0DZW O2T154T6OG 2P3VWU3H10 7V31YC746X E5GY4I6YCZ 5S29HWU6QB

Active Ingredient Monograph aluminum hydroxide digestive aid calcium carbonate digestive aid dihydroxyaluminum sodium carbonate digestive aid magnesium hydroxide digestive aid magnesium trisilicate digestive aid sodium bicarbonate digestive aid sodium citrate digestive aid simethicone digestive aid pancreatin digestive aid pancrelipase digestive aid glutamic acid hydrochloride digestive aid alcohol digestive aid amylase digestive aid anise seed digestive aid aromatic powder digestive aid asafetida digestive aid aspergillus oryza enzymes (except lactase enzyme derived from aspe digestive aid bacillus acidophilus digestive aid bean digestive aid belladonna alkaloids digestive aid belladonna leaves, powdered exrtact digestive aid betaine hydrochloride digestive aid bismuth sodium tartrate digestive aid bismuth subcarbonate digestive aid digestive aid bismuth subgallate black radish powder digestive aid blessed thistle (cnicus benedictus) digestive aid buckthorn digestive aid calcium gluconate digestive aid capsicum digestive aid capsicum, fluid extract of carbon digestive aid carbon digestive aid cascara sagrada extract digestive aid catechu, tinctures digestive aid digestive aid catnip cellulase digestive aid chamomile flowers digestive aid charcoal, wood/activated digestive aid chloroform digestive aid cinnamon oil digestive aid cinnamon tincture digestive aid

Sub-category antacid antacid antacid antacid antacid antacid antacid antiflatulent exocrine pancreatic insufficiency exocrine pancreatic insufficiency stomach acidifier

April 7, 2010

Panel III III III III III III III III II/III II/III II

Pending I I I I I I I I I I II

II/III

III

Final 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(i) 310.545(a)(8)(i) 310.545(a)(8)(i) 310.545(a)(8)(i) 310.545(a)(8)(i)

FR Citation

[58 FR 54454] 310.545(a)(8)(i) 310.545(a)(8)(i) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(iii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii)

OTC Active Ingredients

UNII Code 47EQO8LE7H NH5000009I

8K1MK5E1FY E55SMD6DA8 0F5N573A2Y BIA2SO6F5B V1V998DC17 C5529G5JPQ TE7660XO1C

68JRS2HC1C SC52PT1846 9P2U39H18W ZW3Z11D0JV 1E8C2W13Z0 QTT17582CB 9679TC07X5 XK4IUX8MNB 24H4NWX5CO 64Y2IV7284 33X04XA5AT J2B2A4N98G 9YT4B71U8P CFN6G1F6YK JNJ23Q2COM 3OWL53L36A JC71GJ1F3L 0GG6WIU2KW 269XH13919 E4GA8884NN

Active Ingredient citrus pectin dehyrocholic acid diastase diastase malt dog grass duodenal substance elecampane ether fennel acid galega garlic, dehydrated ginger glycine hectorite hemicellulase homatropine methylbromide horsetail huckleberry hydrastis canadensis (golden seal) hydrastis fluid extract hydrochloric acid iodine iron ox bile johnswort juniper tar kaolin, colloidal knotgrass lactic acid lactose lavender compound, tincture of linden lipase lysine hydrochloride mannitol mycozyme myrrh, fluid extract of nettle nickel-pectin nux vomica extract orthophosphoric acid ox bile extract

Monograph digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid

April 7, 2010

Sub-category

Panel

Pending

III II/III

III III

Final 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i)

FR Citation

OTC Active Ingredients

UNII Code A236A06Y32 KU94FIY6JB 89NA02M4RX V95R5KMY2B V95R5KMY2B V95R5KMY2B ER0CTH01H9 HM5Z15LEBN BQN1B9B9HA

G280W4MW6E AK7JF626KX 451W47IQ8X WIQ1H85SYP 506T60A25R ZLM4P8929R 4J2TY8Y81V H9Y79VD43J 28F9E0DJY8 N8C4A9A49H 62I3C8233L R16CO5Y76E LKG8494WBH 418M5916WG HM4YQM8WRC 7323N7T136 3T8H1794QW R9QTB5E82N 00S42N58OM EM8BM710ZC 0619F35CGV 3J50XA376E 418M5916WG 2R04ONI667 BN34FX42G3 BN34FX42G3 5138Q19F1X

Active Ingredient papain papaya, natural pectin peppermint peppermint oil peppermint spirit pepsin phenacetin potassium bicarbonate potassium carbonate prolase protease rhubarb fluid extract senna sodium chloride sodium salicylate sorbitol stem bromelain strawberry strychnine tannic acid trillium woodruff ipecac syrup aspirin benzyl alcohol camphorated metacresol chloral hydrate chlorobutanol cyclomethycaine sulfate eugenol hexylresorcinol methapyrilene hydrochloride salicylamide tetracaine thymol chloral hydrate eucalyptus oil allyl isothiocyanate allyl isothiocyanate ammonia solution, strong (ammonia water, strong)

Monograph digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid digestive aid emetic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic

April 7, 2010

Sub-category

analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic analgesic & anesthetic counter irritant counter irritant counterirritant fever blister/cold sore fever blister/cold sore

Panel II

Pending II

III

III I IIISE II III III III III I III I III I I I I

I III I I II III III III III II III I III I I I II I

Final 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 337.10 310.545(a)(10)(i) Pending Pending 310.545(a)(10)(i) 310.545(a)(10)(i) 310.545(a)(10)(i) 310.545(a)(10)(i) 310.545(a)(10)(i) 310.545(a)(10)(i) 310.545(a)(10)(i) pending 310.545(a)(10)(i) 310.545(a)(10)(ii) 310.545(a)(10)(ii) pending 310.545(a)(10)(v) 310.545(a)(10)(v)

FR Citation

OTC Active Ingredients

UNII Code R16CO5Y76E 5TJD82A1ET S07O44R1ZM S07O44R1ZM S07O44R1ZM 418M5916WG HM4YQM8WRC 7323N7T136 2R04ONI668 3T8H1794QW R9QTB5E82N 3POA0Q644U L7T10EIP3A 00S42N58OM 7B1AVU9DJN LAV5U5022Y 89NA02M4RX EM8BM710ZC 28F9E0DJY9 3J50XA376E FWV8GJ56ZN H8O4040BHD XJ6RUH0O4G 89DS0H96TB 3K9958V90M 3K9958V90M F5UM2KM3W7 X3S33EX3KW U38V3ZVV3V WV9CM0O67Z V95R5KMY2B R35D29L3ZA 91MBZ8H3QO H8O4040BHD XJ6RUH0O4G SOI2LOH54Z U3RSY48JW5

Active Ingredient aspirin bismuth sodium tartrate camphor (exceding 3 percent) capsaicin capsicum capsicum oleoresin chloral hydrate chlorobutanol cyclomethycaine sulfate eucalyptus oil eugenol glycol salicylate hexylresorcinol histamine dihydrochloride menthol exceeding 1% methapyrilene hydrochloride methyl nicotinate methyl salicylate pectin salicylamide tannic acid thymol tripelennamine hydrochloride trolamine salicylate (triethanolamine salicylate) turpentine oil zinc sulfate alcohol alcohol, ethoxylated alkyl benzalkonium chloride calamine ergot fluidextract ferric chloride panthenol peppermint oil pyrilamine maleate sodium borate trolamine salicylate (trietnanolamine salicylate) turpentine oil zinc oxide zirconium oxide benzocaine

Monograph external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic external analgesic

Sub-category fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting insect bite/sting male genital desensitizer

April 7, 2010

Panel III

Pending III

I I I I II III III I III III III

III

III III I

III I III I

III

Final 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(v) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 310.545(a)(10)(vi) 348.10(a)(1)

FR Citation

OTC Active Ingredients

UNII Code LKG8494WBH NLJ6390P1Z 98PI200988 3K9958V90M R16CO5Y76E PH41D05744 U3RSY48JW9 AMT77LS62O 85474O1N9D 418M5916WG HM4YQM8WRC V1Q0O9OJ9Z 7323N7T136 1O6C93RI7Z 5YZ5R8I73Y 2R04ONI669 3T8H1794QW PDC6A3C0OX

R9QTB5E82N BBX060AN9V SY15A62UPX 1K09F3G675 ND2M416303 7EV65EAW6H RX077P88RY M0T18YH28D 53GH7MZT1R 00S42N58OM WV9CM0O67Z 414P5USJ7F 8UE48MJH8M R35D29L3ZA EM8BM710ZC O414PZ4LPZ TYU5GP6XGE

Active Ingredient benzyl alcohol camphorated metacresol ephedrine hydrochloride lidocaine alcohol aspirin benzethonium chloride benzocaine (0.5 - 1.25%) bithionol calamine cetalkonium chloride chloral hydrate chlorobutanol chlorpheniramine maleate creosote, beechwood cyclomethycaine sulfate dexpanthenol diperodon hydrochloride eucalyptus oil eugenol glycerin glycol salicylate hectorite hexylresorcinol hydrogen peroxide impatiens biflora tincture iron oxide isopropyl alcohol lanolin lead acetate merbromin mercuric chloride methapyrilene hydrochloride panthenol parethoxycaine hydrochloride phenyltoloxamine dihydrogen citrate povidone-vinylacetate copolymers pyrilamine maleate salicylamide salicylic acid simethicone

Sub-category male genital desensitizer male genital desensitizer male genital desensitizer male genital desensitizer poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac

April 7, 2010

Panel

Pending

I III

III

II III

III

I III

III

Final 310.545(a)(10)(iii) 310.545(a)(10)(iii) 310.545(a)(10)(iii) 348.10(a)(2) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii)

FR Citation

OTC Active Ingredients

UNII Code 70FD1KFU70 28F9E0DJY10 3J50XA376E H8O4040BHD XJ6RUH0O4G

344S277G0Z 80EHD8I43D LIF1N9568Y U3RSY48JW10 5TJD82A1ET 5TJD82A1ET LRX7AJ16DT 1O6C93RI7Z L6JW2TJG99 Z97702A5DG SMP2689462 TC2D6JAD43 ZEC193879Q WI4X0X7BPJ WI4X0X7BPJ WI4X0X7BPJ 3X7931PO74 3X7931PO75 3X7931PO76 3X7931PO77 98PI200989 V13007Z41A LT10EIP3A LT10EIP3A 339NCG44TV 4NC0T56V35 88AYB867L5 YUL4LO94HK 8MDF5V39QO 5NF5D4OPCI O8232NY3SJ

Active Ingredient sulfur tannic acid thymol trolamine salicylate (trietnanolamine salicylate) turpentine oil zirconium oxide zyloxin allantoin aluminum acetate aluminum chloride hexahydrate benzocaine butamben picrate camphor camphor cupric sulfate dexpanthenol dibucaine dibucaine hydrochloride dimethisoquin hydrochloride diphenhydramine hydrochloride dyclonine hydrochloride hydrocortisone hydrocortisone (0.25-5%) hydrocortisone (0.5-1%) hydrocortisone acetate hydrocortisone acetate hydrocortisone acetate (0.25-5.0%) hydrocortisone acetate (0.25%-0.5%) juniper tar lidocaine lidocaine hydrochloride menthol menthol (0.1 to 1.0%) obtundia surgical dressing phenol phenolate sodium pramoxine hydrochloride resorcinol sodium bicarbonate tetracaine hydrochloride topical starch

Sub-category poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac

April 7, 2010

Panel

Pending

III III

I I I

IISE I IIIE IIIE I I IISE

I I I I I I I I I I I I I I I I I I I I I

IIIE I I I I I I I IIISE I I I I I I I I I IISE I I I I n/a I IISE

Final 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 310.545(a)(10)(vii) 347.12(a) IISE (0.5-1.25%)

FR Citation

OTC Active Ingredients

UNII Code FWV8GJ56ZN 9O3K93S3TK FM5526K07A SOI2LOH54Z 58H6RWO52I 89Y4M234ES O1GX33ON8R 057Y626693 4U7K4N52ZM 19371312D4 5NF5D4OPCI 5IE62321P4 I16QD7X297 057Y626693 09TD8L5SQV O7TSZ97GEP BBX060AN9V BBX060AN9V BBX060AN9V V95R5KMY2B N9288CD508 8MDF5V39QO K72I3DEX9B C02T02993U R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E 362O9ITL9D SP86R356CC TL2TJE8QTX T3CHA1B51H 7C0697DR9I GN83C131XS R16CO5Y76E R16CO5Y76E R16CO5Y76E 3G6A5W338E

Active Ingredient Monograph tripelennamine hydrochloride external analgesic trolamine external analgesic zinc acetate external analgesic zinc oxide external analgesic bacitracin first aid antibiotic bacitracin zinc first aid antibiotic first aid antibiotic chlortetracycline hydrochloride neomycin sulfate first aid antibiotic first aid antibiotic oxytetracycline hydrochloride (combination only) first aid antibiotic polymyxin b sulfate (combination only) first aid antibiotic tetracycline hydrochloride gramicidin first aid antibiotic neomycin ointment (combination only) first aid antibiotic neomycin sulfate cream first aid antibiotic gingivitis/plaque alkyl dimethyl amine oxide and alkyl dimethyl glycine aloe vera [see aloe] gingivitis/plaque dicalcium phosphate dihydrate [see calcium phosphate, dibasic] gingivitis/plaque hydrogen peroxide and povidone iodine gingivitis/plaque hydrogen peroxide and sodium bicarbonate gingivitis/plaque hydrogen peroxide, sodium citrate, sodium lauryl sulfate, and zinc ch gingivitis/plaque peppermint oil and sage oil gingivitis/plaque gingivitis/plaque polydimethylsiloxane and poloxamer sanguinaria extract gingivitis/plaque sodium bicarbonate gingivitis/plaque stannous pyrophosphate and zinc citrate gingivitis/plaque zinc citrate gingivitis/plaque sodium sulfide (aqueous) ingrown toenail aspirin internal analgesic aspirin (buffered) internal analgesic aspirin internal analgesic aspirin (buffered) internal analgesic acetaminophen internal analgesic acetanilide internal analgesic aminobenzoic acid internal analgesic antipyrine internal analgesic any atropine ingredient internal analgesic any ephedrine ingredient internal analgesic aspirin, aluminum internal analgesic aspirin, calcium internal analgesic aspirin, calcium internal analgesic caffeine internal analgesic

April 7, 2010

Sub-category

Panel

ointment ointment ointment ointment ointment ointment ointment

gel vehicle cardiovascular cardiovascular rheumatologic rheumatologic

I I I I I II II III

III

Pending I IISE IISE IISE I I I I I I I III I I IIISE IIIE IIIE IIISE IIISE IIISE IIIE IIIE IIIE IIIE IIIE IIIE I I I I I I IIS II III

III I I IIIE

Final

333.110(a) 333.110(b) 333.110(c) 333.110(d) 333.120 333.120 333.110(f) 333.120 333.110(e)

538.31 343.12(a) 343.12(b) 343.13(a) 343.13(b)

310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(23)(ii) 310.545(a)(23)(ii) 310.545(a)(23)(i)

FR Citation

OTC Active Ingredients

UNII Code N667F17JP1 N91BDP6H0X Q830PW7520 GSL05Y1MN6 11QV9BS0CB WK2XYI10QM WK2XYI10QM V30V6H1QX4 41728CY7UX KJ5I25TXYL ER0CTH01H9 NYW905655B 8UE48MJH8M 8UE48MJH8M K91YT16P5M R35D29L3ZA A7V27PHC7A EM8BM710ZC V9MO595C9I 75UI7QUZ5J WIQ1H85SYP

5C69YCD2YJ 5C69YCD2YJ E89I1637KE 9C60Y73166

PDC6A3C0OX 506T60A25R T5L8T28FGP RHO26O1T9V NBZ3QY004S DE08037SAB SE337SVY37 SE337SVY37

Active Ingredient calcium salicylate carbaspirin calcium choline salicylate codeine codeine phosphate codeine sulfate ibuprofen ibuprofen iodoantipyrine (idopyrine) lysine aspirin magnesium salicylate methapyrilene fumarate phenacetin pheniramine maleate phenyltoloxamine citrate phenyltoloxamine dihydrogen citrate potassium salicylate pyrilamine maleate quinine salicylamide salsalate sodium para-aminobenzoate sodium salicylate agar alpha cellulose calcium polycarbophil carrageenan (degraded) carrageenan (native) guar gum plantago ovata husks plantago seed psylllium (hemicellulose) sodium carboxymethylcellulose glycerin sorbitol mineral oil magnesium citrate (oral) magnesium hydroxide magnesium sulfate sodium phosphate, dibasic sodium phosphate, monobasic

Monograph internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic internal analgesic laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative

April 7, 2010

Sub-category

Panel

Pending

I I II

I III II III III III II III III II I bulk laxative bulk laxative bulk laxative bulk laxative bulk laxative bulk laxative bulk laxative bulk laxative bulk laxative bulk laxative hyperosmotic hyperosmotic lubricant saline laxative saline laxative saline laxative saline laxative saline laxative

I II II III IIIE III III III II IIISE III II I III III I II III III I I I I I I I I I I I I

Final 310.545(a)(23)(i)

FR Citation

310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(23)(i) [67 FR 54139] [67 FR 54139] 310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(23)(i)

310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(23)(i) 310.545(a)(12)(i)

310.545(a)(12)(i) 310.545(a)(12)(i) 310.545(a)(12)(i)

OTC Active Ingredients

UNII Code Active Ingredient W4888I119H tartaric acid V5VD430YW9, ZY8aloe ingredients (aloe, aloe extract, aloe flower extract) W41H6S09F4 aloin bile salts/acids 568ET80C3D calcium pantothenate J2D46N657D calomel casanthranol cascara fluidextract aromatic cascara sagrada bark 4VBP01X99F cascara sagrada extract cascara sagrada fluidextract castor oil D5340Y2I9G 23H32AOH17 colocynth Z4XE6IBF3V danthron elaterin resin S2D77IH61R frangula gamboge 7556HJ7587 ipomea jalap 4UDO46YBK2 ox bile phenolphthalein 6QK969R2IF podophyllum resin (podophyllin) S8O01I9YLZ prune concentrate dehydrate S8O01I9YLZ prune powder rhubarb, Chinese sodium oleate 399SL044HN 6K7YS503HC docusate calcium sulfosuccinate CIK9F54ZHR docusate potassium sulfosuccinate F05Q2T2JA0 docusate sodium sulfosuccinate poloxamer 10X0709Y6I bisacodyl bran 142M471B3J carbon dioxide, released carboxymethylcellulose sodium K679OBS311 karaya gum R3NBG8914U malt soup extract methylcellulose 4GFU244C4J 9C60Y73166 plantago seed husks [see psyllium seed husks ] 9C60Y73166 plantago seed, blond [see plantago seed] polycarbophil 9C60Y73166 psyllium (hemicellulose) [see plantago seed]

Monograph laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative laxative

Sub-category saline laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stimulant laxative stool softener stool softener stool softener stool softener

April 7, 2010

Panel

Pending I III III III II I I I I I I II I II III II II II III I II III III III III

III I I I I I I I IISE IISE I IISE

Final 310.545(a)(12)(ii) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(B) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(B) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A)

310.545(a)(12)(iii)

FR Citation

OTC Active Ingredients

UNII Code 9C60Y73166

AK7JF626KX S8SJ19N2NX

362O9ITL9D R16CO5Y76E 3G6A5W338E N667F17JP1 N91BDP6H0X Q830PW7520 41728CY7UX WIQ1H85SYP UA8U0KJM72 8UE48MJH8M R35D29L3ZA C137DTR5RG Y62M9GTW4A K73E24S6X9 58JV0P12FY 5WS1632J8W R0JB3224WS 3G6A5W338E T4B6SPQ0UF 68JRS2HC1C 68Y4CF58BV 3K9958V90M SQI2NBY9KR V5VD430YW9 7C0697DR9I GN83C131XS Z1EJP3037Z R16CO5Y76E 3M5V3D1X36 3M5V3D1X36

Active Ingredient psyllium hydrophilic mucilloid psyllium seed psyllium seed (blond) psyllium seed husks senna fluidextract senna pod concentrate senna syrup sennosides a and b acetaminophen aspirin caffeine carbaspirin calcium choline salicylate codeine magnesium salicylate sodium salicylate pamabrom phenyltoloxamine citrate pyrilamine maleate theobromine sodium salicylate theophylline asclepias tuberosa cimicifuga racemosa piscidia erythrina senecio aureus taraxacum officinale ammonium chloride caffeine cinnamedrine hydrochloride homatropine methylbromide pyridoxine hydrochloride alcohol alfalfa leaves aloes any atropine ingredient any ephedrine ingredient asparagus aspirin, calcium barosma bearberry (extract of uva ursi) bearberry fluidextract (extract of bearberry)

Monograph laxative laxative laxative laxative laxative laxative laxative laxative menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic

April 7, 2010

Sub-category

analgesic analgesic analgesic analgesic analgesic analgesic analgesic analgesic antihistamine antihistamine antihistamine antihistamine antihistamine botanical/vegetable herb botanical/vegetable herb botanical/vegetable herb botanical/vegetable herb botanical/vegetable herb diuretic diuretic muscle relaxant muscle relaxant vitamine

Panel

Pending I I I I I/IIIS I/IIIS I/IIIS I

Final

I I III I I II I I I NA I III III II II II II II I I III II III

310.545(a)(24)(i)

I III IIISE III III II II II II II I I IIIE II IIIE

310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i)

310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(ii) 310.545(a)(24)(ii) 310.545(a)(24)(i)

I 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i)

FR Citation

OTC Active Ingredients

UNII Code 6L5ZL09795 KOS935A04V 2URQ2N32W3 568ET80C3D S07O44R1ZM

6L5ZL09795 J9BTD5377V 7D3VB244UX 8K1MK5E1FY 8K1MK5E1FY E1ZT886LR5 U38V3ZVV3V 39R4TAN1VT S72O3284MS 61ZBX54883 ZW3Z11D0JV F2R8V82B84 YNW2QPG8YK DE08037SAB 00S42N58OM J50OIX95QV T42P99266K 25X51I8RD4 AEE24M3MQ9 58FMD0Q0EV V95R5KMY2B ER0CTH01H9 28725X3PV8 28A37T47QO M911911U02 RU45X2JN0Z TLM2976OFR EM8BM710ZC J7WWH9M8QS OJ245FE5EU

Active Ingredient blessed thistle (cnicus benedictus) buchu powdered extract (extract of buchu) calcium lactate calcium pantothenate capsicum oleoresin cascara fluidextract, aromatic (extract of cascara) chlorprophenpyridamine maleate cnicus benedictus collinsonia (extract stone root) corn silk couch grass dog grass extract ethyl nitrate ferric chloride ferrous sulfate gentiana lutea (gentian) glycyrrhiza (licorice) hydrastis canadensis (golden seal) hyoscyamine sulfate juniper oil (oil of juniper) magnesium sulfate methapyrilene hydrochloride methenamine methylene blue natural estrogenic horomone niacinamide nutmeg oil (oil of nutmeg) oil of erigeron parsley peppermint spirit pepsin, essence phenacetin phenindamine tartrate phenyl salicylate pipsissewa potassium acetate potassium nitrate riboflavin salicylamide saw palmetto sodium benzoate

Monograph menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic

April 7, 2010

Sub-category

Panel

Pending

Final 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i)

IIISE 310.545(a)(24)(i) 310.545(a)(24)(i)

FR Citation

OTC Active Ingredients

UNII Code 8M4L3H2ZVZ C151H8M554 M572600E5P 8K1MK5E1FY AD8LJ73GQF 8W8T17847W 3M5V3D1X36 3K9958V90M ND2M416304 G07GZ97H65 SOI2LOH54Z TC2D6JAD44 V9BI9B5YI2 KJ5I25TXYL 00S42N58OM 8UE48MJH8M R35D29L3ZA R0JB3224WS OSD78555ZM LC1V549NOM 451IFR0GXB 3G6A5W338E 362O9ITL9D R0JB3224WS R16CO5Y76E 8GTS82S83M ZQH6VH092Z 25X51I8RD4 SY49TH8VUA EM8BM710ZC M572600E5P H4N855PNZ1 T3CHA1B51H Q2RH0XR1MB R57ZHV85D8 4NRT660KJQ IY191986AO 969IQC5YJU

Active Ingredient sodium nitrate sucrose sulferated oils of turpentine thiamine hydrochloride triticum turpentine, venice (venice turpentine) urea uva ursi, extract of alcohol isopropyl alcohol clotrimazole zinc oxide diphenhydramine hydrochloride doxylamine succinate methapyrilene fumarate methapyrilene hydrochloride phenyltoloxamine dihydrogen citrate pyrilamine maleate ammonium bromide potassium bromide sodium bromide scopolamine aminoxide hydrobromide scopolamine hydrobromide caffeine acetaminophen ammonium chloride aspirin diphenhydramine citrate ginseng niacinamide passion flower extract salicylamide thiamine hydrochloride vitamin E antipyrine piperocaine hydrochloride boric acid mild silver protein sulfacetamide sodium yellow mercuric oxide infusion of rose petals

Monograph menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic menstrual/diuretic mercury mercury n/a n/a nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid nighttime sleep aid ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic

April 7, 2010

Sub-category

antihistamine antihistamine antihistamine antihistamine antihistamine antihistamine bromide bromide bromide scopolamine compound scopolamine compound stimulant

Panel

Pending

II I I I I IIISE IISE IIS IIS IISE IIISE IISE IISE IISE IIS IIS I IISE II IIE

III III II II III III II II II II II II II

Final 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(24)(i)

FR Citation

[67 FR 5942] 352.10(r) 338.10(a) [5 FR 6828] [54 FR 6826] [54 FR 6826] [54 FR 6826] [54 FR 6826] [54 FR 6826] [54 FR 6826] [54 FR 6826] [54 FR 6826] [54 FR 6826] 54 FR 6826 [54 FR 6826] 338.10(b)

II II II II II anesthetic anesthetic anti-infective anti-infective anti-infective anti-infective astringent

II II III III II III III

IIE II II II II II II II II III

[54 FR 6826]

310.545(a)(21)(i) 310.545(a)(21)(i) 310.545(a)(21)(ii) 310.545(a)(21)(ii) 310.545(a)(21)(ii) 310.545(a)(21)(iii)

OTC Active Ingredients

UNII Code 89DS0H96TB K679OBS311 7SA290YK68 2G86QN327L PDC6A3C0OX 273FM27VK1 3NXW29V3WO 4GFU244C4J 5655G9Y8AQ B697894SGQ 30IQX730WE 6OZP39ZG8H 532B59J990 FZ989GH94E 6DC9Q167V3

T5L8T28FGP T5L8T28FGP I9O0E3H2ZE 4T6H12BN9U 4T6H12BN9U 7G1J5DA97F 2ZA36H0S2V 451W47IQ8X NLJ6390P1Z MZ1131787D 04JA59TNSJ 04JA59TNSJ 0YZT43HS7D 367E55FXGW 059QF0KO0R T3CHA1B51H R16CO5Y76E U3RSY48JW11 LKG8494WBH

Active Ingredient zinc sulfate carboxymethylcellulose sodium dextran 70 gelatin glycerin hydroxyethylcellulose hydroxypropyl methycellulose hypromellose methylcellulose polyethylene glycol 300 polyethylene glycol 400 polyethylene glycol 6000 polyols, liquid polysorbate 80 polyvinyl alcohol povidone propylene glycol lanolin (in combination) lanolin, anhydrous (in combination) mineral oil mineral oil, light paraffin petrolatum petrolatum, white wax, white wax, yellow white ointment sodium chloride ephedrine hydrochloride naphazoline hydrochloride phenylephrine hydrochloride phenylephrine hydrochloride (0.08 to 0.2%) tetrahydrozoline hydrochloride lanolin nonionic derivatives peruvian balsam oil water and additives water, purified antipyrine aspirin benzocaine benzyl alcohol

Monograph ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic ophthalmic oral health care oral health care oral health care oral health care

Sub-category astringent demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents demulcents emollient emollient emollient emollient emollient emollient emollient emollient emollient emollient hypertonic agent vasoconstrictor vasoconstrictor vasoconstrictor vasoconstrictor vasoconstrictor

anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic

April 7, 2010

Panel I I I I I I I I I I NA I I I I I I I I I NA I I NA I I I I III I I I

II I I I

Pending I I I I I I I I I I I III I I I I I I I I I I I I I I I I III I I I I I II IIIE I I

Final 349.10 349.12(a)(1) 349.12(b) 349.12(c) 349.12(d)(1) 349.12(a)(2) 349.12(a)(3) 349.12(a)(4) 349.12(d)(2) 349.12(d)(3) 310.545(a)(21)(iv) 349.12(d) 349.12(d)(4) 349.12(e) 349.12(f) 349.12(d)(5) 349.14(a)(2) 349.14(a)(1) 349.14(b)(2) 349.14(b)(1) 349.14(b)(3) 349.14(b)(4) 349.14(b)(6) 349.14(b)(7) 349.14(b)(8) 349.14(b)(5) 349.16 349.18(a) 349.18(b) 310.545(a)(21)(v) 349.18(c) 349.18(d) 349.14

349.20 310.545(a)(14)

FR Citation

OTC Active Ingredients

UNII Code 5TJD82A1ET 1MXY2UM8NV L6JW2TJG99 Z97702A5DG ZEC193879Q RV6J6604TK R9QTB5E82N 98PI200990 V13007Z41A LT10EIP3A LAV5U5022Y 339NCG44TV 4NC0T56V35 R35D29L3ZA 0619F35CGV 5NF5D4OPCI 3J50XA376E DPU64XYB1D JC71GJ1F3L 91QY4PXU8Q 2G86QN327L 89NA02M4RX 506T60A25R R0JB3224WS 7A72MUN24Z 1C4QK22F9J 5TJD82A1ET 1MXY2UM8NV 31PZ2VAU81 BBX060AN9V 8MDF5V39QO Y9UKD0XE6F 3K9958V90M 1L24V9R23S 8SKN0B0MIM 62TEY51RR4 31PZ2VAU81 31PZ2VAU81

Active Ingredient camphor cresol dibucaine dibucaine hydrochloride dyclonine hydrochloride eucalyptol hexylresorcinol lidocaine lidocaine hydrochloride menthol methyl salicylate phenol phenolate sodium pyrilamine maleate tetracaine tetracaine hydrochloride thymol alum, ammonium myrrh tincture elm bark gelatin pectin sorbitol sugars ammonium chloride horehound potassium iodide camphor cresol carbamide peroxide (in anhydrous glycerin) hydrogen peroxide sodium bicarbonate sodium perborate monohydrate alcohol alum, potassium amyltricresols, secondary benzoic acid bismuth subsalicylate boroglycerin carbamide peroxide carbamide peroxide

Monograph oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care

Sub-category anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic anesthetic/analgesic astringent astringent demulcents demulcents demulcents demulcents demulcents expectorant expectorant expectorant non-antimicrobal non-antimicrobal wound cleansing wound cleansing wound cleansing wound cleansing

April 7, 2010

Panel II II II II I III I II II I III I I II II II III I II I I I

Pending IISE IISE II II I III I II II I III I I II II II III I II I I I III III

Final

310.545(a)(14) 310.545(a)(14) 310.545(a)(14) 310.545(a)(14) 310.545(a)(14) 310.545(a)(14)

310.545(a)(14) 310.545(a)(14) 310.545(a)(14) 310.545(a)(14) 310.545(a)(14)

310.545(a)(14) 310.545(a)(14)

III III II 310.545(a)(14) 310.545(a)(14) I I I II III

I I I I IIISE I IIISE IIIE IISE IISE III IIIE

FR Citation

OTC Active Ingredients

UNII Code D9OM4SK49P XYS8INN1I6 R4CY19YS7C U38V3ZVV3V J4Z741D6O5 PDC6A3C0OX BBX060AN9V BBX060AN9V 9679TC07X6 RU6242GP15 5UTX5635HP 04JA59TNSJ 8D5I63UE1Q H35KS68EE7 85H0HZU99M FA1N0842KB 91MBZ8H3QO 91MBZ8H3QO 9XTM81VK2B Y52BK1W96C 3J50XA376E TD2LE91MBE 86Q357L16B Q40Q9N063P U3RSY48JW12 31PZ2VAU81 PDC6A3C0OX PDC6A3C0OX ND2M416305 ND2M416306 2P3VWU3H10 362O9ITL9D 5QB0T2IUN0 5QB0T2IUN0 R16CO5Y76E 3G6A5W338E 0E53J927NA C2E1CI501T

Active Ingredient cetylpyridinium chloride chlorophyllin copper complex dequalinium chloride domiphen bromide ferric chloride gentian violet glycerin hydrogen peroxide hydrogen peroxide iodine meralein sodium nitromersol oxyquinoline phenylephrine hydrochloride phenylpropanolamine hydrochloride potassium chlorate povidone-iodine salicyl alcohol sodium borate sodium borate monohydrate sodium caprylate sodium dichromate sodium perborate thymol iodide tolu balsam zinc chloride acetic acid benzocaine carbamide peroxide 6.5% (in anhydrous glycerin) glycerin glycerine and anhydrous glycerine isopropyl alcohol isopropyl alcohol charcoal, activated acetaminophen aluminum hydroxide aluminum hydroxide gel aspirin caffeine magnesium carbonate magnesium trisilicate

Monograph Sub-category oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care oral health care otic otic otic otic otic otic otic overindulgence in a hangover minimizer overindulgence in a hangover reliever overindulgence in a hangover reliever overindulgence in a hangover reliever overindulgence in a hangover reliever overindulgence in a hangover reliever overindulgence in a hangover reliever overindulgence in a hangover reliever

April 7, 2010

Panel

Pending IIISE IIIE IIISE IIISE IISE IIE I III IIIE IIISE IISE IISE IIISE

Final

FR Citation

III III

III I

IISE IIISE I IISE IISE IIIE IISE IIISE IIISE I 310.545(a)(15)(i) IISE I IIIE

[51 FR 28660] 344.10 [51 FR 28660] 310.545(a)(15)(ii) 344.12 310.545(a)(15)(ii)

IIIE I I I I I I I

[48 FR 32873]

OTC Active Ingredients

UNII Code 1Q73Q2JULR 6YSS42VSEV 62TEY51RR5 WIQ1H85SYP ZUM06L90GV ZUM06L90GV U3RSY48JW13 LKG8494WBH N863NB338G CIW5S16655 789U1901C5 F05Q2T2JA0 F05Q2T2JA0 0YIW783RG1 ZLT174DL7U LWK91TU9AH 6DC9Q167V3 6NAF1689IO 70FD1KFU70 2P3VWU3H10 62I3C8233L 62I3C8233L 62I3C8233L 89DS0H96TB U3RSY48JW14 U3RSY48JW15 L7J6A1NE81 LKG8494WBH LKG8494WBH PAU39W3CVB PAU39W3CVB 5TJD82A1ET S07O44R1ZM S07O44R1ZM 2968PHW8QP

Active Ingredient sodium acetylsalicylate (in solution) sodium citrate in solution fructose bismuth subsalicylate sodium salicylate pyrethrum extract (combination) pyrethrum extract (combination) benzocaine benzyl alcohol benzyl benzonate chlorophenothane (dichlorodiphenyl trichloroethane) coconut oil soap, aqueous copper oleate dichlorodiphenyl trichloroethane (DDT) dioctyl sodium sulfosuccinate docusate sodium formic acid isobornyl thiocycanoacetate picrotoxin piperonyl butoxide (combination) propylene glycol sabadilla, alkaloids sulfur, sublimed thiocyanoacetate charcoal, activated ipecac fluidextract ipecac syrup ipecac tincture zinc sulfate benzocaine benzocaine benzoin tincture, compound benzyl alcohol benzyl alcohol butacaine sulfate butacaine sulfate camphor capsicum capsicum chlorophyllin citric acid

Monograph Sub-category overindulgence in a hangover reliever overindulgence in a hangover reliever/overindulgence overindulgence in a inebriation minimizer overindulgence in a overindulgence overindulgence in alcohol/food pediculicide aresol pediculicide non-aresol pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide pediculicide poison treatment poison treatment poison treatment poison treatment poison treatment relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort

April 7, 2010

Panel

I II II II

Pending I I IIIE I I I I II II II

II II II II

II II

II II II II

II II II II I II I II II I IIIE I I IIISE I IIISE IISE IIIE IISE IIISE IIIE

Final

FR Citation

[48 FR 32873]

310.545(a)(25)(ii) 358.61 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i)

310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(ii) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(25)(i) 310.545(a)(16) 310.545(a)(16) 310.545(a)(16)

OTC Active Ingredients

UNII Code

1MXY2UM8NV 1MXY2UM8NV 7FLD91C86K 3T8H1794QW 1HG84L3525 LT10EIP3A LAV5U5022Y LAV5U5022Y JC71GJ1F3L 339NCG44TV 339NCG44TV 4NC0T56V35 4NC0T56V35 TUF2IVW3M2 1Q73Q2JULR 8ZYQ1474W7 8ZYQ1474W7 C810JCZ56Q 3FTR44B32Q 5R78837D4A 5R78837D4A 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E XV74C1N1AE 1364PS73AF 3K9958V90M DPU64XYB1D 1L24V9R23S 80EHD8I43D I7T908772F F5UM2KM3W7 PH41D05744 U3RSY48JW16

Active Ingredient creosote creosote, beechwood cresol cresol edetate disodium eugenol formaldehyde solution menthol methyl salicylate methyl salicylate myrrh phenol phenol phenolate sodium phenolate sodium poloxamer 407 reosote sodium citrate sodium fluoride sodium fluoride sodium monolfuorophosphate stannous fluoride strontium chloride strontium chloride thymol thymol thymol iodide thymol iodide hydroquinone mercury, ammoniated acetone alcohol alum, ammonium alum, potassium aluminum acetate aluminum chlorhydroxy complex aluminum sulfate, anhydrous aromatics benzalkonium chloride benzethonium chloride benzocaine

Monograph relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort relief of oral discomfort skin bleach skin bleach skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent skin protectant astringent

April 7, 2010

Sub-category

Panel

II II II II I II I II II II II

Pending IIIE IIISE IIISE IIISE IISE IIISE IIIE IIS IISE IISE IIISE I IIISE I IIISE IIIE IIISE IIIE IIIE IISE IIIE IIIE IIIE IISE IIIE IIIE IIIE IIIE I

I I

Final

310.545(a)(17) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 347.12(a) 310.545(a)(18)(ii) 347.12(b) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii)

FR Citation

OTC Active Ingredients

UNII Code 8SKN0B0MIM R57ZHV85D9 Y882YXF34X 5TJD82A1ET 578389D6D0 8PI54V663Y 1MXY2UM8NV LRX7AJ16DT 2R04ONI670 3T8H1794QW 3QJ8WS6V8H Y9H1V576FH ND2M416307 L7T10EIP3A LAV5U5022Y 61VUG75Y3P V95R5KMY2B 339NCG44TV GTP1P30292 0462U14DUI U27K0H1H2O 95IT3W8JZE 91MBZ8H3QO 26WJH3CS0B 7SEV7J4R1U 7SEV7J4R1U 28F9E0DJY15 3J50XA376E O8232NY3SJ 101I4J0U34 86Q357L16B SOI2LOH54Z 4O71YT5YB5 H92E6QA4FV 89DS0H96TB 8T66I31YNK 80EHD8I43D 5QB0T2IUN0 5QB0T2IUN0 SMD1X3XO9M

Active Ingredient benzoic acid boric acid calcium acetate camphor gum clove oil colloidal oatmeal cresol cupric sulfate eucalyptus oil eugenol ferric subsulfate (Monsel's solution) honey isopropyl alcohol menthol methyl salicylate oxyquinoline sulfate peppermint oil phenol polyoxeythylene laurate potassium ferrocyanide p-t-butyl-m-cresol sage oil silver nitrate sodium borate sodium diacetate talc talc tannic acid glycerite thymol topical starch witch hazel zinc chloride zinc oxide zinc phenolsulfonate zinc stearate zinc sulfate aldioxa aluminum acetate aluminum hydroxide aluminum hydroxide cellulose, microporous

Monograph skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant

April 7, 2010

Sub-category astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent astringent diaper rash diaper rash diaper rash diaper rash diaper rash

Panel II II II II II II II II II II II II II II

Pending II

II II II II II II II II II II II II II I II II II II II

IISE

I II

Final 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 347.12(c) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(ii)

IIISE IIISE 310.545(a)(18)(iii) 310.545(a)(18)(iii) IIISE

FR Citation

OTC Active Ingredients

UNII Code 1C6V77QF41 512OYT1CRR 512OYT1CRR BBL281NWFG 8PI54V663Y ZT934N0X4W 1O6C93RI7Z 92RU3N3Y1O PDC6A3C0OX PDC6A3C0OX 24H4NWX5CO 7EV65EAW6H N6K5787QVP 367E55FXGW 367E55FXGW 88AYB867L5 73JWT2K6T3 YUL4LO94HK 70FD1KFU70 7SEV7J4R1U 28F9E0DJY11 28F9E0DJY14 O8232NY3SJ 81G40H8B0T 3NY3SM6B8U FM5526K07A EQR32Y7H0M YIW503MI7V R57ZHV85D10 512OYT1CRR 92RU3N3Y1O PDC6A3C0OX 68Y4CF58BV 70FD1KFU70 28F9E0DJY12 O8232NY3SJ 9O3K93S3TK 89DS0H96TB 3K9958V90M 3K9958V90M

Active Ingredient cholecalciferol cocoa butter cocoa butter cod liver oil colloidal oatmeal cysteine hydrochloride dexpanthenol dimethicone glycerin glycerine and anhydrous glycerine kaolin lanolin minaeral oil peruvian balsam peruvian balsam oil pramoxine hydrochloride protein hydrolysate racemethionine resorcinol sulfur talc tannic acid tannic acid topical starch vitamin A yeast cell derivative, live zinc acetate zinc carbonate bismuth subnitrate boric acid cocoa butter dimethicone glycerin pyridoxine hydrochloride sulfur tannic acid topical starch trolamine zinc sulfate alcohol alcohol, ethoxylated alkyl

Sub-category diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash diaper rash fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore fever blister/cold sore insect bites/stings insect bites/stings

April 7, 2010

Panel

Pending IIISE III iii

Final 310.545(a)(18)(iii) 310.545(a)(18)(iii)

III 310.545(a)(18)(iii)

II II

IIISE I IIISE III I I I IIIE III

310.545(a)(18)(iii) 310.545(a)(18)(iii)

III III

310.545(a)(18)(iii) 310.545(a)(18)(iii)

II I II II I IIISE IIIE III III II II I I I

310.545(a)(18)(iii)

II II

310.545(a)(18)(iii) 310.545(a)(18)(iii)

310.545(a)(18)(iii) 310.545(a)(18)(iii) 310.545(a)(18)(iv) 310.545(a)(18)(iv)

310.545(a)(18)(iv) 310.545(a)(18)(iv) 310.545(a)(18)(iv) 310.545(a)(18)(iv) 310.545(a)(18)(iv) 310.545(a)(18)(iv) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A)

FR Citation

OTC Active Ingredients

UNII Code 5138Q19F1X 5138Q19F1X F5UM2KM3W7 5TJD82A1ET X3S33EX3KW U38V3ZVV3V PDC6A3C0OX LT10EIP3A V95R5KMY2B 339NCG44TV R35D29L3ZA R35D29L3ZA 91MBZ8H3QO 9O3K93S3TK XJ6RUH0O4G 2ZA36H0S2V YIW503MI7V R57ZHV85D11 936JST6JCN 230OU9XXE4 8CRQ2TH63M 3NY3SM6B8U 4B24275HEU 2KR89I4H1Y 3K9958V90M PH41D05744 U3RSY48JW17 LKG8494WBH YIW503MI7V AMT77LS62O R57ZHV85D12 5TJD82A1ET 85474O1N9D 418M5916WG V1Q0O9OJ9Z 5YZ5R8I73Y TC2D6JAD45

Active Ingredient ammonia solution, strong ammonium hydroxide benzalkonium chloride camphor ergot fluid extract ferric chloride glycerin menthol obtundia surgical dressing peppermint oil phenol pyrilamine maleate pyrilamine maleate sodium borate trolamine turpentine oil zirconium oxide beeswax bismuth subnitrate boric acid cetyl alcohol glyceryl stearate isopropyl palmitate live yeast cell derivative shark liver oil stearyl alcohol alcohol anion and cation exchange resins buffered benzethonium chloride benzocaine benzyl alcohol bismuth subnitrate bithionol boric acid camphor cetalkonium chloride chloral hydrate chlorpheniramine maleate creosote diperodon hydrochloride diphenhydramine hydrochloride

Sub-category Panel insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings insect bites/stings w/ sales less than $25,000 insect bites/stings w/ sales less than $2 II insect bites/stings w/ sales less than $2 II insect bites/stings w/ sales less than $25,000 insect bites/stings w/ sales less than $25,000 insect bites/stings w/ sales less than $25,000 insect bites/stings w/ sales less than $2 III insect bites/stings w/ sales less than $2 I insect bites/stings w/ sales less than $25,000 poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac II poison ivy/oak/sumac poison ivy/oak/sumac II poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac

April 7, 2010

Pending

IISE

Final 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(vi) 310.545(a)(18)(v)(A)

IISE

II II

III I

II II

310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A)

FR Citation

OTC Active Ingredients

UNII Code 2R04ONI671 PDC6A3C0OX BBX060AN9V SY15A62UPX 1K09F3G675 ND2M416308 7EV65EAW6H 7EV65EAW6H RX077P88RY 98PI200991 LT10EIP3A M0T18YH28D 53GH7MZT1R WV9CM0O67Z 68E52E5J67 339NCG44TV 8UE48MJH8M R35D29L3ZA O414PZ4LPZ TYU5GP6XGE 28F9E0DJY13 O8232NY3SJ 9O3K93S3TK XJ6RUH0O4G

2ZA36H0S2V YIW503MI7V R57ZHV85D13 936JST6JCN 230OU9XXE4 8CRQ2TH63M 3NY3SM6B8U 4B24275HEU 2KR89I4H1Y 2ZA36H0S2V YIW503MI7V R57ZHV85D14

Active Ingredient eucalyptus oil ferric acid glycerine and anhydrous glycerine hectorite hydrogen peroxide impatiens biflora tincture iron oxide isopropyl alcohol lanolin lanolin lead acetate lidocaine menthol merbromin mercuric chloride panthenol parethoxycaine hydrochloride phenol phenyltoloxamine dihydrogen citrate povidone-vinylacetate copolymers pyrilamine maleate salicylic acid simethicone tannic acid topical starch trolamine turpentine oil zirconium oxide zyloxin beeswax bismuth subnitrate boric acid cetyl alcohol glyceryl stearate isopropyl palmitate live yeast cell derivative shark liver oil stearyl alcohol beeswax bismuth subnitrate boric acid

Sub-category Panel Pending poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac IISE poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac II II poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac poison ivy/oak/sumac w/ sales less than $25,000 II II poison ivy/oak/sumac w/ sales less than II II poison ivy/oak/sumac w/ sales less than poison ivy/oak/sumac w/ sales less than $25,000 poison ivy/oak/sumac w/ sales less than $25,000 poison ivy/oak/sumac w/ sales less than $25,000 III poison ivy/oak/sumac w/ sales less than III I I poison ivy/oak/sumac w/ sales less than poison ivy/oak/sumac w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 II II w/ sales less than $25,000 II II

April 7, 2010

Final 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(B)

FR Citation

OTC Active Ingredients

UNII Code 936JST6JCN 230OU9XXE4 8CRQ2TH63M 3NY3SM6B8U 4B24275HEU 2KR89I4H1Y 28F9E0DJY14 3NY3SM6B8U FM5526K07A 3K9958V90M 344S277G0Z 344S277G0Z 5QB0T2IUN0 H19J064BA5 512OYT1CRR 8PI54V663Y O8232NY3SJ 92RU3N3Y1O PDC6A3C0OX 8334LX7S21 24H4NWX5CO 7EV65EAW6H T5L8T28FGP 4T6H12BN9U 4T6H12BN9U 8MDF5V39QO 70FD1KFU70 O8232NY3SJ O8232NY3SJ FM5526K07A EQR32Y7H0M SOI2LOH54Z R0JB3224WS 3G6A5W338E ZQH6VH092Z H4N855PNZ1 93NOD9WBCS 344S277G0Z 376KTP06K8 TL2TJE8QTX

Active Ingredient cetyl alcohol glyceryl stearate isopropyl palmitate live yeast cell derivative shark liver oil stearyl alcohol tannic acid yeast cell derivative, live zinc acetate alcohol allantoin allantoin (wound healing claims only) aluminum hydroxide gel bismuth subnitrate calamine cocoa butter colloidal oatmeal corn starch dimethicone glycerin hard fat kaolin lanolin mineral oil petrolatum petrolatum, white sodium bicarbonate sulfur topical starch topical starch zinc acetate zinc carbonate zinc oxide ammonium chloride caffeine ginseng vitamin E 2-ethylhexyl-4-phenylbenzophenone-2-carboxylic acid allantoin (with aminobenzoic acid) amiloxate (isoamyl p-methoxycinnamate) aminobenzoic acid (PABA)

Monograph skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant skin protectant stimulant stimulant stimulant stimulant sunscreen sunscreen sunscreen sunscreen

Sub-category w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 w/ sales less than $25,000 wound healing wound healing agent wound healing agent

April 7, 2010

Panel

Pending

III I

I I

II IIISE I IISE I III I IIS I I I I I I

I II I I II I I

I I I II

I I I

II II NA I

I I I NA II I IIISE I I I IIE I IIE IIE IISE IIIE I

Final 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(A) 310.545(a)(18)(i)(B) 310.545(a)(18)(i)(A)

FR Citation

347.10(a) 310.545(a)(18)(i)(A) 347.10(b) 347.10(c) 347.10(d) 347.10(f) 347.10(q) 347.10(g) 347.10(h) 347.10(i) 347.10(j) 347.10(k) 347.10(l) 347.10(m) 347.10(r) 347.10(o) 310.545(a)(18)(i)(A) 347.10(q) 310.545(a)(18)(iv) 347.10(s) 347.10(t) 347.10(u) [39 FR 6104] 340.10 [39 FR 6104] [39 FR 6104] 58 FR 28281 58 FR 28281 352.10(a)

OTC Active Ingredients

UNII Code G63QQF2NOX PWZ1720CBH 8NT850T0YS LU86E5P72A 5TJD82A1ET 5437O7N5BH 2UTZ0QC864 PGQ9BY2MDE B762XZ551X 5X93W9OFZL M94R1PM439 9YQ9DI1W42 8I3XWY40L9 54M9O25201 A886B5N5IM V06SV4M95S TLH4A6LV1W J9QGD60OUZ 4Y5P7MUD51 4X49Y0596W 5A68WGF6WM 95OOS7VE0Y 77FU10423X 77FU10423X Z11006CMUZ 25K35WQ32Q 1W6L629B4K 15FIX9V2JP H8O4040BHD SOI2LOH54Z 4O71YT5YB5 5QB0T2IUN0

Active Ingredient Monograph Sub-category avobenzone sunscreen bemotrizinol sunscreen bisoctrizole sunscreen bornelone (5-(3,3-dimethyl-2-norbornyliden)3-pentene-2-one) sunscreen camphor sunscreen cinoxate sunscreen diethylhexyl butamido triazone sunscreen digalloyl trioleate sunscreen diolamine methoxycinnamate (diethanolamine methoxycinnamate) sunscreen dioxybenzone sunscreen sunscreen dipropylene glycol salicylate drometrizole trisiloxane sunscreen ecamsule sunscreen ensulizole (phenylbenzimidazole sulfonic acid) sunscreen enzacamene (4-methylbenzylidene camphor) sunscreen sunscreen ethyl 4-[bis(hydroxypropyl)] aminobenzoate (roxadimate) sunscreen glyceryl aminobenzoate (lisadimate, glyceryl PABA) homosalate sunscreen lawsone (w/ dihydroxyacetone) sunscreen meradimate (menthyl anthranilate) sunscreen octinoxate (octyl methoxycinnamate; ethylhexyl methoxycinnamate) sunscreen sunscreen octisalate (octyl salicylate; ethylhexyl salicylate) octocrylene sunscreen sunscreen octyl triazone (ethylhexyl triazone) oxybenzone (benzophenone-3) sunscreen padimate a (5 percent or higher) sunscreen padimate a (up to 5 percent) sunscreen padimate o sunscreen red petrolatum sunscreen sunscreen sodium 3, 4-dimethylphenyl-glyoxylate sulisobenzone sunscreen titanium dioxide sunscreen trolamine salicylate sunscreen zinc oxide sunscreen zinc phenol sulfonate sunscreen aluminum hydroxide topical analgesic diaper rash dodecaethylene glycol monolaurate (polyethylene glycol 600 monolauvaginal contraceptive laureth 10S vaginal contraceptive menfegol vaginal contraceptive mercury-containing ingredients vaginal contraceptive vaginal contraceptive methoxypolyoxyethyleneglycol 550 laurate

April 7, 2010

Panel NA NA III inactive I NA I I I III NA NA I I I I I I I I I NA I I I I II I I I

Pending

Final 352.10(a)

IIIE

FR Citation

58 FR 28281 43 FR 38208

352.10(c)

I I I IIISE

310.545(a)(29) 310.545(a)(29) 352.10(e)

352.10(n)

I I I I I I I I

310.545(a)(29) 310.545(a)(29) 352.10(f) 310.545(a)(29) 352.10(h) 352.10(j) 352.10(k) 352.10(i)

I IISE IIISE I I IISE I I I III

352.10(l)

58 FR 28281

64 FR 27670 64 FR 27670

352.10(m) 310.545(a)(29) [64 FR 27682] 352.10(o) 352.10(p) 352.10(q) 352.10(r) [64 FR 27682]

IIIE IIIE I IIIE

310.545(a)(10)(iv) 310.545(a)(28)(i) 310.545(a)(28)(i) 310.545(a)(28)(i) 310.545(a)(28)(i)

OTC Active Ingredients

UNII Code nonylphenoxypoly 7JPC6Y25QS OSX88361UX CG8692ZN14 O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ Q40Q9N063P Q40Q9N063P PQ6CK8PD0R U3RSY48JW18 568ET80C3D 5TJD82A1ET D5340Y2I9G 9679TC07X7 33X04XA5AT LT10EIP3A 3K9958V90M SQI2NBY9KR 8C3Z4148WZ 6Y89129C8H 94ZLA3W45F PQ6CK8PD0R 3M5V3D1X36 U3RSY48JW19 6SO6U10H04 KOS935A04V KOS935A04V 3G6A5W338E U26EO4675Q H0G9379FGK 2URQ2N32W3 568ET80C3D K679OBS311 5C69YCD2YJ 1C6V77QF41 N91BDP6H0X XR12Z4HLEA

Active Ingredient nonoxynol 9 octoxynol 9 phenylmercuric acetate phenylmercuric nitrate salicylic acid salicylic acid salicylic acid acetic acid acetic acid, glacial ascorbic acid benzocaine calcium pantothenate camphor castor oil iodine lactic acid menthol alcohol alfalfa alginic acid anise oil arginine ascorbic acid bearberry benzocaine biotin bone marrow, red buchu buchu, potassium extract caffeine caffeine citrate calcium calcium carbonate calcium caseinate calcium lactate calcium pantothenate carboxymethylcellulose sodium carrageenan cholecalciferol choline chondrus

Monograph Sub-category vaginal contraceptive vaginal contraceptive vaginal contraceptive vaginal contraceptive wart remover collodoin-like vehicle wart remover karaya gum, glycol plaster vehicle wart remover plaster vehicle wart remover wart remover wart remover wart remover wart remover wart remover wart remover wart remover wart remover wart remover weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control

April 7, 2010

Panel

I I III III III II III II II II III II

Pending I I IIS IIS I I IISE IIISE IIISE IIIE IISE IIIE IISE IISE IISE IIIE IISE II II III II II II II IISE II II II II II II II II II II II III III II II III

Final

FR Citation

310.545(a)(28)(ii) 310.545(a)(28)(i) 310.545(a)(28)(i) 358.110(b) 358.110(c) 358.110(a) [55 FR 33254] [55 FR 33254] [55 FR 33254] [55 FR 33254] [55 FR 33254] [55 FR 33254] [55 FR 33254] [55 FR 33254] [55 FR 33254] [55 FR 33254] 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20)

OTC Active Ingredients

UNII Code 2968PHW8QP 6L5ZL09795 789U1901C5 789U1901C5 8470G57WFM 9G5L16BK6N LRX7AJ16DT P6YC3EG204 48TCX9A1VT IY9XDZ35W2 F05Q2T2JA0 VS041H42XC UVP74NG1C5 QK8899250F R5L488RY0Q U1B11I423Z 39R4TAN1VT 4110YT348C 935E97BOY8 6YSS42VSEV E89I1637KE 4QD397987E S1EFO94F35 4L6452S749 9679TC07X8 04Y7590D77

J2B2A4N98G GMW67QNF9C K3Z4F929H6 JNJ23Q2COM I38ZP9992A 3A3U0GI71G 7CVR7L4A2D 4Z2OA6A13N

Active Ingredient citric acid cnicus benedictus copper copper gluconate corn oil corn silk, potassium extract corn syrup cupric sulfate cyanocobalamin (vitamin B12) cystine dextrose docusate sodium ergocalciferol ferric ammonium citrate ferric pyrophosphate ferrous fumarate ferrous gluconate ferrous sulfate (iron) flax seed folic acid fructose guar gum histidine hydrastis canadensis inositol iodine isoleucine juniper, potassium extract karaya gum kelp lactose lecithin leucine liver concentrate lysine lysine hydrochloride magnesium magnesium oxide malt maltodextrin manganese citrate

Monograph weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control weight control

April 7, 2010

Sub-category

Panel

Pending II II II II II II II II II II II II II II II II II II II II II III II II II II II II III III II II II II II II II II II II II

Final 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20)

FR Citation

OTC Active Ingredients

UNII Code 3OWL53L36A AE28F7PNPL 4GFU244C4J 25X51I8RD4 FQ3DRG0N5K 19F5HK2737 A236A06Y32 KU94FIY6JB ER0CTH01H9 47E5O17Y3R 8D5I63UE1Q 27YLU75U4W 11E6VI8VEG 9C60Y73166 EE90ONI6FF 68Y4CF58BV TLM2976OFR FST467XS7D 7Y1255HVXR 8MDF5V39QO 7473P66J9E 451W47IQ8X R44IWB3RN5 C151H8M554 M572600E5P 8K0I04919X 2ZD004190S K4C08XP666 8DUH1N11BX 42HK56048U HG18B9YRS7 9ZP99WL196

Active Ingredient mannitol methionine methylcellulose mono- and di-glycerides niacinamide organic vegetables pancreatin pantothenic acid papain papaya enzymes pepsin phenacetin phenylalanine phenylpropanolamine hydrochloride phosphorus phytolacca pineapple enzymes plantago seed potassium citrate pyridoxine hydrochloride (vitamin B6) riboflavin rice polishings saccharin sea minerals sesame seed sodium sodium bicarbonate sodium caseinate sodium chloride (salt) soy meal soybean protein sucrose thaimine hydrochloride (vitamin B1) thaimine mononitrate (vitamine B1 mononitrate) threonine tricalcium phosphate tryptophan tyrosine uva ursi, potassium extract valine vegetable (green)

April 7, 2010

Sub-category

Panel

Pending II II III II II II II II II II II II II I/IIS II II II III II II II II II II II II III II II II II II II II II II II II II II II

FR Citation

OTC Active Ingredients

UNII Code 81G40H8B0T

H4N855PNZ1 YR3G369F5A TTV12P4NEE 3NY3SM6B8U

Active Ingredient vitamin A vitamin A acetate vitamin A palmitate vitamin E wheat germ xanthan gum yeast

Monograph weight control weight control weight control weight control weight control weight control weight control

April 7, 2010

Sub-category

Panel

Pending II II II II II III II

Final 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20)

FR Citation