(a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses:

(1) Topical acne drug products.

AlcloxaAlkyl isoquinolinium bromideAluminum chlorohydrexAluminum hydroxideBenzocaineBenzoic acidBoric acidCalcium polysulfideCalcium thiosulfateCamphorChloroxylenolCloxyquinCoal tarDibenzothiopheneEstroneMagnesium aluminum silicateMagnesium sulfatePhenolPhenolate sodiumPhenyl salicylatePovidone-iodinePyrilamine maleateResorcinol (as single ingredient)Resorcinol monoacetate (as single ingredient)Salicylic acid (over 2 up to 5 percent)Sodium borateSodium thiosulfateTetracaine hydrochlorideThymolVitamin EZinc oxideZinc stearateZinc sulfide

(2) Anticaries drug products—(i) Approved as of May 7, 1991.

Hydrogen fluorideSodium carbonateSodium monofluorophosphate (6 percent rinse)Sodium phosphate

(ii) Approved as of October 7, 1996.

Calcium sucrose phosphateDicalcium phosphate dihydrateDisodium hydrogen phosphate 1

1 These ingredients are nonmonograph except when used to prepare acidulated phosphate fluoride treatment rinses identified in § 355.10(a)(3) of this chapter.

Phosphoric acid 1Sodium dihydrogen phosphateSodium dihydrogen phosphate monohydrateSodium phosphate, dibasic anhydrous reagent 1

(3) Antidiarrheal drug products—(i) Approved as of May 7, 1991.

Aluminum hydroxideAtropine sulfateCalcium carbonateCarboxymethylcellulose sodiumGlycineHomatropine methylbromideHyoscyamine sulfateLactobacillus acidophilusLactobacillus bulgaricusOpium, powderedOpium tinctureParegoricPhenyl salicylateScopolamine hydrobromideZinc phenolsulfonate

(ii) Approved as of April 19, 2004; April 18, 2005, for products with annual sales less than $25,000.

Attapulgite, activatedBismuth subnitrateCalcium hydroxideCalcium polycarbophilCharcoal (activated)PectinPolycarbophilPotassium carbonateRhubarb fluidextract

(4) Antiperspirant drug products—(i) Ingredients—Approved as of May 7, 1991.

Alum, potassiumAluminum bromohydrateAluminum chloride (alcoholic solutions)Aluminum chloride (aqueous solution) (aerosol only)Aluminum sulfateAluminum sulfate, buffered (aerosol only)Sodium aluminum chlorohydroxy lactate

(ii) Approved as of December 9, 2004; June 9, 2005, for products with annual sales less than $25,000.

Aluminum sulfate buffered with sodium aluminum lactate

(5) [Reserved]

(6) Cold, cough, allergy, bronchodilator, and antiasthmatic drug products—(i) Antihistamine drug products—(A) Ingredients.

Methapyrilene hydrochlorideMethapyrilene fumarateThenyldiamine hydrochloride

(B) Ingredients.

Phenyltoloxamine dihydrogen citrateMethapyrilene hydrochlorideMethapyrilene fumarateThenyldiamine hydrochloride

(ii) Nasal decongestant drug products—(A) Approved as of May 7, 1991.

Allyl isothiocyanateCamphor (lozenge)Creosote, beechwood (oral)Eucalyptol (lozenge)Eucalyptol (mouthwash)Eucalyptus oil (lozenge)Eucalyptus oil (mouthwash)Menthol (mouthwash)Peppermint oil (mouthwash)Thenyldiamine hydrochlorideThymolThymol (lozenge)Thymol (mouthwash)Turpentine oil

(B) Approved as of August 23, 1995.

Bornyl acetate (topical) Cedar leaf oil (topical) Creosote, beechwood (topical)Ephedrine (oral) Ephedrine hydrochloride (oral) Ephedrine sulfate (oral) Racephedrine hydrochloride (oral/topical)

(C) Approved as of April 11, 2007; October 11, 2007, for products with annual sales less than $25,000. Any ingredient(s) labeled with claims or directions for use for sinusitis or for relief of nasal congestion associated with sinusitis.

(iii) Expectorant drug products.

Ammonium chlorideAntimony potassium tartrateBeechwood creosoteBenzoin preparations (compound tincture of benzoin, tincture of benzoin)CamphorChloroformEucalyptol/eucalyptus oilHorehound Iodides (calcium iodide anyhydrous, hydroidic acid syrup, iodized lime, potassium iodide)IpecacIpecac fluidextractIpecac syrupMenthol/peppermint oilPine tar preparations (extract white pine compound, pine tar, syrup of pine tar, compound white pine syrup, white pine)Potassium guaiacolsulfonateSodium citrateSquill preparations (squill, squill extract)Terpin hydrate preparations (terpin hydrate, terpin hydrate elixir)Tolu preparations (tolu, tolu balsam, tolu balsam tincture)Turpentine oil (spirits of turpentine)

(iv) Bronchodilator drug products—(A) Approved as of October 2, 1987.

Aminophylline Belladonna alkaloids Euphorbia pilulifera Metaproterenol sulfate Methoxyphenamine hydrochloride Pseudoephedrine hydrochloride Pseudoephedrine sulfate Theophylline, anhydrous Theophylline calcium salicylate Theophylline sodium glycinate

(B) Approved as of January 29, 1996. Any combination drug product containing theophylline (e.g., theophylline and ephedrine, or theophylline and ephedrine and phenobarbital).

(C) Approved as of June 19, 1996. Any ingredient(s) in a pressurized metered-dose inhaler container.

(D) Approved as of October 29, 2001. Any oral bronchodilator active ingredient (e.g., ephedrine, ephedrine hydrochloride, ephedrine sulfate, racephedrine hydrochloride, or any other ephedrine salt) in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient.

(7) Dandruff/seborrheic dermatitis/psoriasis drug products.

Alkyl isoquinolinium bromideAllantoinBenzalkonium chlorideBenzethonium chlorideBoric acidCalcium undecylenateCaptanChloroxylenolColloidal oatmealCresol, saponatedEthohexadiolEucalyptolJuniper tarLauryl isoquinolinium bromideMenthol Mercury oleateMethylbenzethonium chlorideMethyl salicylatePhenolPhenolate sodiumPine tarPovidone-iodineResorcinolSodium borateSodium salicylateThymolUndecylenic acid

(8) Digestive aid drug products—(i) Approved as of May 7, 1991.

Bismuth sodium tartrateCalcium carbonateCellulaseDehydrocholic acidDihydroxyaluminum sodium carbonateDuodenal substanceGarlic, dehydratedGlutamic acid hydrochlorideHemicellulaseHomatropine methylbromideMagnesium hydroxideMagnesium trisilicateOx bile extractPancreatinPancrelipasePapainPeppermint oilPepsinSodium bicarbonateSodium citrateSorbitol

(ii) Approved as of November 10, 1993.

Alcohol Aluminum hydroxide Amylase Anise seed Aromatic powderAsafetida Aspergillus oryza enzymes (except lactase enzyme derived from Aspergillus oryzae) Bacillus acidophilus Bean Belladonna alkaloids Belladonna leaves, powdered extract Betaine hydrochloride Bismuth subcarbonate Bismuth subgallate Black radish powder Blessed thistle (cnicus benedictus) Buckthorn Calcium gluconate Capsicum Capsicum, fluid extract of Carbon Cascara sagrada extract Catechu, tincture Catnip Chamomile flowers Charcoal, wood Chloroform Cinnamon oil Cinnamon tincture Citrus pectin Diastase Diastase malt Dog grass Elecampane Ether Fennel acid Galega Ginger Glycine Hydrastis canadensis (golden seal) Hectorite Horsetail Huckleberry Hydrastis fluid extract Hydrochloric acid Iodine Iron ox bile Johnswort Juniper Kaolin, colloidal Knotgrass Lactic acid Lactose Lavender compound, tincture ofLinden Lipase Lysine hydrochloride Mannitol Mycozyme Myrrh, fluid extract of Nettle Nickel-pectin Nux vomica extract Orthophosphoric acid Papaya, natural Pectin Peppermint Peppermint spirit Phenacetin Potassium bicarbonate Potassium carbonate Protease Prolase Rhubarb fluid extract Senna Sodium chloride Sodium salicylate Stem bromelain StrawberryStrychnine Tannic acid Trillium Woodruff

(iii) Charcoal, activated

(9) [Reserved]

(10) External analgesic drug products—(i) Analgesic and anesthetic drug products.

AspirinChloral hydrateChlorobutanolCyclomethycaine sulfateEugenolHexylresorcinolMethapyrilene hydrochlorideSalicylamideThymol

(ii) Counterirritant drug products.

Chloral hydrateEucalyptus oil

(iii) Male genital desensitizer drug products.

Benzyl alcoholCamphorated metacresolEphedrine hydrochloride

(iv) Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.

(v) Fever blister and cold sore treatment drug products.

Allyl isothiocyanate Aspirin Bismuth sodium tartrate Camphor (exceeding 3 percent) Capsaicin Capsicum Capsicum oleoresin Chloral hydrate Chlorobutanol Cyclomethycaine sulfateEucalyptus oil Eugenol Glycol salicylate Hexylresorcinol Histamine dihydrochloride Menthol (exceeding 1 percent) Methapyrilene hydrochloride Methyl nicotinate Methyl salicylate Pectin Salicylamide Strong ammonia solution Tannic acid Thymol Tripelennamine hydrochloride Trolamine salicylate Turpentine oil Zinc sulfate

(vi) Insect bite and sting drug products.

Alcohol Alcohol, ethoxylated alkyl Benzalkonium chloride Calamine Ergot fluidextract Ferric chloride Panthenol Peppermint oil Pyrilamine maleate Sodium borate Trolamine salicylate Turpentine oil Zinc oxide Zirconium oxide

(vii) Poison ivy, poison oak, and poison sumac drug products.

Alcohol Aspirin Benzethonium chloride Benzocaine (0.5 to 1.25 percent) 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 Sulfur Tannic acid Thymol Trolamine salicylate Turpentine oil Zirconium oxide Zyloxin

(11) [Reserved]

(12) Laxative drug products—(i)(A) Bulk laxatives.

AgarCarrageenan (degraded)Carrageenan (native)Guar gun

(i)(B) Bulk laxatives—Approved as of March 29, 2007.

Granular dosage forms containing psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago husks, or plantago seed including, but not limited to, any granules that are:(1) Swallowed dry prior to drinking liquid,(2) Dispersed, suspended, or partially dissolved in liquid prior to swallowing,(3) Chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid, or(4) Sprinkled over food.

(ii) Saline laxative.

Tartaric acid

(iii) Stool softener.

Poloxamer 188

(iv)(A) Stimulant laxatives—Approved as of May 7, 1991.

Aloin Bile salts/acids Calcium pantothenate Calomel Colocynth Elaterin resin Frangula Gamboge Ipomea Jalap Ox bile Podophyllum resin Prune concentrate dehydratePrune powder Rhubarb, Chinese Sodium Oleate

(iv)(B) Stimulant laxatives—Approved as of January 29, 1999.

DanthronPhenolphthalein

(C) Stimulant laxatives—Approved as of November 5, 2002.

Aloe ingredients (aloe, aloe extract, aloe flower extract)Cascara sagrada ingredients (casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, cascara sagrada fluidextract).

(13) [Reserved]

(14) Oral health care drug products (nonantimicrobial).

Antipyrine Camphor Cresol Dibucaine Dibucaine hydrochloride Eucalyptol LidocaineLidocaine hydrochloride Methly salicylate Myrrh tincture Pyrilamine maleate Sorbitol Sugars Tetracaine Tetracaine hydrochloride Thymol

(15) Topical otic drug products—(i) For the prevention of swimmer’s ear and for the drying of water-clogged ears, approved as of May 7, 1991.

Acetic acid

(ii) For the prevention of swimmer’s ear, approved as of August 15, 1995.

Glycerin and anhydrous glycerinIsopropyl alcohol

(16) Poison treatment drug products.

Ipecac fluidextract Ipecac tincture Zinc sulfate

(17) Skin bleaching drug products.

Mercury, ammoniated

(18) Skin protectant drug products—(i)(A) Ingredients—Approved as of May 7, 1991.

Allantoin (wound healing claims only)SulfurTannic acidZinc acetate (wound healing claims only)

(B) Ingredients—Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000.

BeeswaxBismuth subnitrateBoric acidCetyl alcoholGlyceryl stearateIsopropyl palmitateLive yeast cell derivativeShark liver oilStearyl alcohol

(ii) Astringent drug products.

Acetone AlcoholAlum, ammonium Alum, potassium Aluminum chlorhydroxy complex Aromatics Benzalkonium chloride Benzethonium chloride Benzocaine Benzoic acid Boric acid Calcium acetate (except calcium acetate monohydrate when combined with aluminum sulfate tetradecahydrate to provide an aluminum acetate solution as described in § 347.20(b) of this chapter)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 P-t-butyl-m-cresol Peppermint oil Phenol Polyoxeythylene laurate Potassium ferrocyanide Sage oil Silver nitrate Sodium borate Sodium diacetate Talc Tannic acid glycerite Thymol Topical starch Zinc chloride Zinc oxide Zinc phenolsulfonate Zinc stearate Zinc sulfate

(iii) Diaper rash drug products.

Aluminum hydroxide Cocoa butter Cysteine hydrochloride Glycerin Protein hydrolysate Racemethionine Sulfur Tannic acid Zinc acetate Zinc carbonate

(iv) Fever blister and cold sore treatment drug products.

Bismuth subnitrate Boric acid Pyridoxine hydrochloride Sulfur Tannic acid Topical starch Trolamine Zinc sulfate

(v) Insect bite and sting drug products—(A) Ingredients—Approved as of November 10, 1993.

AlcoholAlcohol, ethoxylated alkylAmmonia solution, strongAmmonium hydroxideBenzalkonium chlorideCamphorErgot fluid extractFerric chlorideMentholPeppermint oilPhenolPyrilamine maleateSodium borateTrolamineTurpentine oilZirconium oxide

(B) Ingredients—Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000.

BeeswaxBismuth subnitrateBoric acidCetyl alcoholGlyceryl stearateIsopropyl palmitateLive yeast cell derivativeShark liver oilStearyl alcohol

(vi) Poison ivy, poison oak, and poison sumac drug products—(A) Ingredients—Approved as of November 10, 1993.

AlcoholAnion and cation exchange resins bufferedBenzethonium chlorideBenzocaineBenzyl alcoholBismuth subnitrateBithionolBoric acidCamphorCetalkonium chlorideChloral hydrateChlorpheniramine maleateCreosoteDiperodon hydrochlorideDiphenhydramine hydrochlorideEucalyptus oilFerric chlorideGlycerinHectoriteHydrogen peroxideImpatiens biflora tinctureIron oxideIsopropyl alcoholLanolinLead acetateLidocaineMentholMerbrominMercuric chloridePanthenolParethoxycaine hydrochloridePhenolPhenyltoloxamine dihydrogen citratePovidone-vinylacetate copolymersSalicylic acidSimethiconeTannic acidTopical starchTrolamineTurpentine oilZirconium oxideZyloxin

(B) Ingredients—Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000.

BeeswaxBismuth subnitrateBoric acidCetyl alcoholGlyceryl stearateIsopropyl palmitateLive yeast cell derivativeShark liver oilStearyl alcohol

(19) [Reserved]

(20) Weight control drug products.

AlcoholAlfalfaAlginic acidAnise oilArginineAscorbic acidBearberryBiotinBone marrow, redBuchuBuchu, potassium extractCaffeineCaffeine citrateCalciumCalcium carbonateCalcium caseinateCalcium lactateCalcium pantothenateCarboxymethylcellulose sodiumCarrageenanCholecalcierolCholineChondrusCitric acidCnicus benedictusCopperCopper gluconateCorn oilCorn syrupCorn silk, potassium extractCupric sulfateCyanocobalamin (vitamin B12)CystineDextroseDocusate sodiumErgocalciferolFerric ammonium citrateFerric pyrophosphateFerrous fumarateFerrous gluconateFerrous sulfate (iron)Flax seedFolic acidFructoseGuar gumHistidineHydrastis canadensisInositolIodineIsoleucineJuniper, potassium extractKaraya gumKelpLactoseLecithinLeucineLiver concentrateLysineLysine hydrochlorideMagnesiumMagnesium oxideMaltMaltodextrinManganese citrateMannitolMethionineMethylcelluloseMono- and di-glyceridesNiacinamideOrganic vegetablesPancreatinPantothenic acidPapainPapaya enzymesPepsinPhenacetinPhenylalaninePhosphorusPhytolaccaPineapple enzymesPlantago seedPotassium citratePyridoxine hydrochloride (vitamin B6)RiboflavinRice polishingsSaccharinSea mineralsSesame seedSodiumSodium bicarbonateSodium caseinateSodium chloride (salt)Soybean proteinSoy mealSucroseThiamine hydrochloride (vitamin B1)Thiamine mononitrate (vitamin B1 mononitrate)ThreonineTricalcium phosphateTryptophanTyrosineUva ursi, potassium extractValineVegetableVitamin AVitamin A acetateVitamin A palmitateVitamin EWheat germXanthan gumYeast

(21) Ophthalmic drug products. (i) Ophthalmic anesthetic drug products.

AntipyrinePiperocaine hydrochloride

(ii) Ophthalmic anti-infective drug products.

Boric acidMild silver proteinYellow mercuric oxide

(iii) Ophthalmic astringent drug products.

Infusion of rose petals

(iv) Ophthalmic demulcent drug products.

Polyethylene glycol 6000

(v) Ophthalmic vasoconstrictor drug products.

Phenylephrine hydrochloride (less than 0.08 percent)

(22) Topical antifungal drug products. (i) Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.

(ii) Ingredients.

Alcloxa Alum, potassium Aluminum sulfate Amyltricresols, secondary Basic fuchsin Benzethonium chloride Benzoic acid Benzoxiquine Boric acid Camphor Candicidin Chlorothymol Coal tar Dichlorophen Menthol Methylparaben Oxyquinoline Oxyquinoline sulfate Phenol Phenolate sodium Phenyl salicylate Propionic acid Propylparaben Resorcinol Salicylic acid Sodium borate Sodium caprylate Sodium propionate Sulfur Tannic acid Thymol Tolindate Triacetin Zinc caprylate Zinc propionate

(iii) Any ingredient(s) labeled with claims or directions for use on the scalp or on the nails.

(iv) Ingredients.

Camphorated metacresol Chloroxylenol m-cresol Nystatin

(23) Internal analgesic drug products—(i) Approved as of November 10, 1993.

Aminobenzoic acid Antipyrine Aspirin, aluminum Calcium salicylate Codeine Codeine phosphate Codeine sulfate Iodoantipyrine Lysine aspirin Methapyrilene fumarate Phenacetin Pheniramine maleate Pyrilamine maleate Quinine Salsalate Sodium aminobenzoate

(ii) Approved as of February 22, 1999.

Any atropine ingredientAny ephedrine ingredient

(24) Orally administered menstrual drug products—(i) Approved as of November 10, 1993.

Alcohol Alfalfa leaves Aloes Asclepias tuberosa Asparagus Barosma Bearberry (extract of uva ursi) Bearberry fluidextract (extract of bearberry) Blessed thistle (cnicus benedictus) Buchu powdered extract (extract of buchu) Calcium lactate Calcium pantothenate Capsicum oleoresin Cascara fluidextract, aromatic (extract of cascara) Chlorprophenpyridamine maleate Cimicifuga racemosa Codeine Collinsonia (extract stone root) Corn silk Couch grass Dog grass extract Ethyl nitrite Ferric chloride Ferrous sulfate Gentiana lutea (gentian) Glycyrrhiza (licorice) Homatropine methylbromide Hydrangea, powdered extract (extract of hydrangea) Hydrastis canadensis (golden seal) Hyoscyamine sulfate Juniper oil (oil of juniper) Magnesium sulfate Methapyrilene hydrochloride Methenamine Methylene blue Natural estrogenic hormone Niacinamide Nutmeg oil (oil of nutmeg) Oil of erigeron Parsley Peppermint spirit Pepsin, essence Phenacetin Phenindamine tartrate Phenyl salicylate Piscidia erythrina Pipsissewa Potassium acetate Potassium nitrate Riboflavin Saw palmetto Senecio aureus Sodium benzoate Sodium nitrate Sucrose Sulferated oils of turpentine Taraxacum officinale Theobromine sodium salicylate Theophylline Thiamine hydrochloride Triticum Turpentine, venice (venice turpertine) Urea

(ii) Approved as of February 22, 1999.

Any atropine ingredientAny ephedrine ingredient

(25) Pediculicide drug products—(i) Approved as of November 10, 1993.

Benzocaine Benzyl alcohol Benzyl benzoate Chlorophenothane (dichlorodiphenyl trichloroethane) Coconut oil soap, aqueous Copper oleate Docusate sodium Formic acid Isobornyl thiocyanoacetate Picrotoxin Propylene glycol Sabadilla alkaloids Sulfur, sublimed Thiocyanoacetate

(ii) Approved as of June 14, 1994. The combination of pyrethrum extract (formerly named pyrethrins) and piperonyl butoxide in an aerosol dosage formulation.

(26) Anorectal drug products—(i) Anticholinergic drug products.

AtropineBelladonna extract

(ii) Antiseptic drug products.

Boric acidBoroglycerinHydrastisPhenolResorcinolSodium salicylic acid phenolate

(iii) Astringent drug products.

Tannic acid

(iv) Counterirritant drug products.

Camphor (greater than 3 to 11 percent)HydrastisMenthol (1.25 to 16 percent)Turpentine oil (rectified) (6 to 50 percent)

(v) Keratolytic drug products.

Precipitated sulfurSublimed sulfur

(vi) Local anesthetic drug products.

DiperodonPhenacaine hydrochloride

(vii) Other drug products.

Collinsonia extractEscherichia coli vaccinesLappa extractLeptandra extractLive yeast cell derivativeMullein

(viii) Protectant drug products.

Bismuth oxideBismuth subcarbonateBismuth subgallateBismuth subnitrateLanolin alcohols

(ix) Vasoconstrictor drug products.

Epinephrine undecylenate

(x) Wound healinq drug products.

CholecalciferolCod liver oilLive yeast cell derivativePeruvian balsamShark liver oilVitamin A

(xi) Combination drug products. Any combination drug product containing hydrocortisone and pramoxine hydrochloride.

(27) Topical antimicrobial drug products—(i) First aid antiseptic drug products.

Ammoniated mercuryCalomel (mercurous chloride)Merbromin (mercurochrome)Mercufenol chloride (ortho-chloromercuriphenol, ortho-hydroxyphenylmercuric chloride)Mercuric chloride (bichloride of mercury, mercury chloride)Mercuric oxide, yellowMercuric salicylateMercuric sulfide, redMercuryMercury oleateMercury sulfideNitromersolPara-chloromercuriphenolPhenylmercuric nitrateThimerosalVitromersolZyloxin

(ii) Diaper rash drug products.

Para-chloromercuriphenolAny other ingredient containing mercury

(iii) Consumer antiseptic hand wash drug products. Approved as of September 6, 2017.

CloflucarbanFluorosalanHexachloropheneHexylresorcinolIodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)Methylbenzethonium chlorideNonylphenoxypoly (ethyleneoxy) ethanoliodinePhenol (greater than 1.5 percent)Phenol (less than 1.5 percent)Poloxamer iodine complexPovidone-iodine (5 to 10 percent)Secondary amyltricresolsSodium oxychloroseneTribromsalanTriclocarbanTriclosanTriple DyeUndecoylium chloride iodine complex

(iv) Consumer antiseptic body wash drug products. Approved as of September 6, 2017.

CloflucarbanFluorosalanHexachloropheneHexylresorcinolIodine complex (phosphate ester of alkylaryloxy polyethylene glycol)Iodine tinctureMethylbenzethonium chlorideNonylphenoxypoly (ethyleneoxy) ethanoliodinePhenol (greater than 1.5 percent)Phenol (less than 1.5 percent)Poloxamer iodine complexPovidone-iodine (5 to 10 percent)Secondary amyltricresolsSodium oxychloroseneTribromsalanTriclocarbanTriclosanTriple DyeUndecoylium chloride iodine complex

(v) [Reserved]

(vi) Health care personnel hand wash drug products. Approved as of December 20, 2018.

CloflucarbanFluorosalanHexachloropheneHexylresorcinolIodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)Methylbenzethonium chlorideNonylphenoxypoly (ethyleneoxy) ethanoliodinePhenolPoloxamer-iodine complexSecondary amyltricresolsSodium oxychloroseneTribromsalanTriclocarbanTriclosanUndecoylium chloride iodine complex

(vii) [Reserved]

(viii) Surgical hand scrub drug products. Approved as of December 20, 2018.

CloflucarbanFluorosalanHexachloropheneHexylresorcinolIodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)Methylbenzethonium chlorideNonylphenoxypoly (ethyleneoxy) ethanoliodinePhenolPoloxamer-iodine complexSecondary amyltricresolsSodium oxychloroseneTribromsalanTriclocarbanTriclosanUndecoylium chloride iodine complex

(ix) [Reserved]

(x) Patient antiseptic skin preparation drug products. Approved as of December 20, 2018.

CloflucarbanFluorosalanHexachloropheneHexylresorcinolIodine complex (phosphate ester of alkylaryloxy polyethylene glycol)Iodine tincture (USP)Iodine topical solution (USP)Mercufenol chlorideMethylbenzethonium chlorideNonylphenoxypoly (ethyleneoxy) ethanoliodinePhenolPoloxamer-iodine complexSecondary amyltricresolsSodium oxychloroseneTribromsalanTriclocarbanTriclosanTriple dyeUndecoylium chloride iodine complexCombination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivativeCombination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol

(28) Vaginal contraceptive drug products—(i) Approved as of October 22, 1998.

Dodecaethylene glycol monolaurate (polyethylene glycol 600 monolaurate)Laureth 10SMethoxypolyoxyethyleneglycol 550 lauratePhenylmercuric acetatePhenylmercuric nitrateAny other ingredient containing mercury

(ii) Approved as of November 5, 2002.

Octoxynol 9

(29) Sunscreen drug products. (i) Ingredients.

Diethanolamine methoxycinnamateDigalloyl trioleateEthyl 4-[bis(hydroxypropyl)] aminobenzoateGlyceryl aminobenzoateLawsone with dihydroxyacetoneRed petrolatum

(ii) Any ingredients labeled with any of the following or similar claims. Instant protection or protection immediately upon application.

Claims for “all-day” protection or extended wear claims citing a specific number of hours of protection that is inconsistent with the directions for application in 21 CFR 201.327.

(30) [Reserved]

(b) Any OTC drug product that is labeled, represented, or promoted for the uses specified and containing any active ingredient(s) as specified in paragraph (a) of this section is regarded as a new drug within the meaning of section 210(p) of the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under section 505 of the Act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the Act.

(c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for the OTC uses and containing any active ingredient(s) as specified in paragraph (a) of this section is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.

(d) Any OTC drug product that is not in compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(42) of this section.

(1) May 7, 1991, for products subject to paragraphs (a)(1) through (a)(2)(i), (a)(3)(i), (a)(4)(i), (a)(6)(i)(A), (a)(6)(ii)(A), (a)(7) (except as covered by paragraph (d)(3) of this section), (a)(8)(i), (a)(10)(i) through (a)(10)(iii), (a)(12)(i)(A), (a)(12)(ii) through (a)(12)(iv)(A), (a)(14) through (a)(15)(i), (a)(16) through (a)(18)(i)(A), (a)(18)(ii) (except as covered by paragraph (d)(22) of this section), (a)(18)(iii), (a)(18)(iv), (a)(18)(v)(A), and (a)(18)(vi)(A) of this section.

(2) February 10, 1992, for products subject to paragraph (a)(20) of this section.

(3) December 4, 1992, for products subject to paragraph (a)(7) of this section that contain menthol as an antipruritic in combination with the antidandruff ingredient coal tar identified in § 358.710(a)(1) of this chapter. This section does not apply to products allowed by § 358.720(b) of this chapter after April 5, 2007.

(4) February 28, 1990, for products subject to paragraph (a)(6)(iii) of this section, except those that contain ipecac.

(5) September 14, 1993, for products subject to paragraph (a)(6)(iii) of this section that contain ipecac.

(6) December 9, 1993, for products subject to paragraph (a)(6)(i)(B) of this section.

(7) March 6, 1989, for products subject to paragraph (a)(21) of this section, except those that contain ophthalmic anti-infective ingredients listed in paragraph (a)(21)(ii).

(8) June 18, 1993, for products subject to paragraph (a)(21) of this section that contain ophthalmic anti-infective ingredients.

(9) June 18, 1993, for products subject to paragraph (a)(10)(iv) of this section.

(10) June 18, 1993, for products subject to paragraph (a)(22)(i) of this section.

(11) November 10, 1993, for products subject to paragraphs (a)(8)(ii), (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except products that contain ferric subsulfate as covered by paragraph (d)(22) of this section and except products that contain calcium acetate monohydrate as covered by paragraph (d)(39) of this section) through (a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii), (a)(23)(i), (a)(24)(i), and (a)(25) of this section.

(12) March 2, 1994, for products subject to paragraph (a)(22)(iii) of this section.

(13) August 5, 1991, for products subject to paragraph (a)(26) of this section, except for those that contain live yeast cell derivative and a combination of hydrocortisone and pramoxine hydrochloride.

(14) September 2, 1994, for products subject to paragraph (a)(26)(vii) and (a)(26)(x) of this section that contain live yeast cell derivative.

(15) September 23, 1994, for products subject to paragraph (a)(22)(iv) of this section.

(16) June 14, 1994, for products subject to paragraph (a)(25)(ii) of this section.

(17) April 19, 2004, for products subject to paragraph (a)(3)(ii) of this section. April 18, 2005, for products with annual sales less than $25,000.

(18) August 15, 1995, for products subject to paragraph (a)(15)(ii) of this section.

(19) October 2, 1987, for products subject to paragraph (a)(6)(iv)(A) of this section.

(20) January 29, 1996, for products subject to paragraph (a)(6)(iv)(B) of this section.

(21) April 21, 1994, for products subject to paragraph (a)(8)(iii) of this section.

(22) April 21, 1993, for products subject to paragraph (a)(18)(ii) of this section that contain ferric subsulfate.

(23) August 23, 1995, for products subject to paragraph (a)(6)(ii)(B) of this section.

(24) October 7, 1996, for products subject to paragraph (a)(2)(ii) of this section.

(25) June 19, 1996, for products subject to paragraph (a)(6)(iv)(C) of this section.

(26) February 22, 1999, for products subject to paragraphs (a)(23)(ii) and (a)(24)(ii) of this section.

(27) [Reserved]

(28) October 22, 1998, for products subject to paragraphs (a)(27) and (a)(28)(i) of this section.

(29) January 29, 1999, for products subject to paragraph (a)(12)(iv)(B) of this section.

(30) November 5, 2002, for products subject to paragraph (a)(12)(iv)(C) of this section.

(31) December 31, 2002, for products subject to paragraph (a)(29)(i) of this section.

(32) June 4, 2004, for products subject to paragraphs (a)(18)(i)(B), (a)(18)(v)(B), and (a)(18)(vi)(B) of this section. June 6, 2005, for products with annual sales less than $25,000.

(33) October 29, 2001, for products subject to paragraph (a)(6)(iv)(D) of this section.

(34) December 9, 2004, for products subject to paragraph (a)(4)(ii) of this section. June 9, 2005, for products with annual sales less than $25,000.

(35) [Reserved]

(36) November 5, 2002, for products subject to paragraph (a)(28)(ii) of this section.

(37) September 25, 2003, for products subject to paragraph (a)(26)(xi) of this section.

(38) October 1, 2007, for products subject to paragraph (a)(12)(i)(B) of this section.

(39) September 6, 2010, for products subject to paragraph (a)(18)(ii) of this section that contain calcium acetate monohydrate, except as provided in § 347.20(b) of this chapter.

(40) December 17, 2012, for products subject to paragraph (a)(29)(ii) of this section. December 17, 2013, for products with annual sales less than $25,000.

(41) September 6, 2017, for products subject to paragraph (a)(27)(iii) or (iv) of this section.

(42) December 20, 2018, for products subject to paragraphs (a)(27)(vi) through (x) of this section.

[55 FR 46919, Nov. 7, 1990]Editorial Note:For Federal Register citations affecting § 310.545, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.Effective Date Note:At 61 FR 9571, Mar. 8, 1996, in § 310.545 in paragraph (a)(6)(ii)(B), the entry for “l-desoxyephedrine (topical)” was stayed until further notice.