(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
(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 Sec. 355.10(a)(3) of this chapter.--------------------------------------------------------------------------- Phosphoric acid \1\Sodium 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
(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
(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
(i) Antihistamine drug products--(A) Ingredients. Methapyrilene hydrochlorideMethapyrilene fumarateThenyldiamine hydrochloride
(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
(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 oilHorehoundIodides (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. AminophyllineBelladonna alkaloidsEuphorbia piluliferaMetaproterenol sulfateMethoxyphenamine hydrochloridePseudoephedrine hydrochloridePseudoephedrine sulfateTheophylline, anhydrousTheophylline calcium salicylateTheophylline sodium glycinate
(A) Approved as of October 2, 1987. AminophyllineBelladonna alkaloidsEuphorbia piluliferaMetaproterenol sulfateMethoxyphenamine hydrochloridePseudoephedrine hydrochloridePseudoephedrine sulfateTheophylline, anhydrousTheophylline calcium salicylateTheophylline 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 bromideMentholMercury 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
(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. AlcoholAluminum hydroxideAmylaseAnise seedAromatic powderAsafetidaAspergillus oryza enzymes (except lactase enzyme derived from Aspergillus oryzae)Bacillus acidophilusBeanBelladonna alkaloidsBelladonna leaves, powdered extractBetaine hydrochloride Bismuth subcarbonateBismuth subgallateBlack radish powderBlessed thistle (cnicus benedictus)BuckthornCalcium gluconateCapsicumCapsicum, fluid extract ofCarbonCascara sagrada extractCatechu, tinctureCatnipChamomile flowersCharcoal, woodChloroformCinnamon oilCinnamon tinctureCitrus pectinDiastaseDiastase maltDog grassElecampaneEtherFennel acidGalegaGingerGlycineHydrastis canadensis (golden seal)HectoriteHorsetailHuckleberryHydrastis fluid extractHydrochloric acidIodineIron ox bileJohnswortJuniperKaolin, colloidalKnotgrassLactic acidLactoseLavender compound, tincture ofLindenLipaseLysine hydrochlorideMannitolMycozymeMyrrh, fluid extract ofNettleNickel-pectinNux vomica extractOrthophosphoric acidPapaya, naturalPectinPeppermintPeppermint spiritPhenacetinPotassium bicarbonatePotassium carbonateProteaseProlaseRhubarb fluid extractSennaSodium chlorideSodium salicylateStem bromelainStrawberryStrychnineTannic acidTrilliumWoodruff
(iii) Charcoal, activated
(9) [Reserved]
(10) External analgesic drug products--(i) Analgesic and anesthetic drug products. AspirinChloral hydrateChlorobutanolCyclomethycaine sulfateEugenolHexylresorcinolMethapyrilene hydrochlorideSalicylamideThymol
(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 isothiocyanateAspirinBismuth sodium tartrateCamphor (exceeding 3 percent)CapsaicinCapsicumCapsicum oleoresinChloral hydrateChlorobutanolCyclomethycaine sulfateEucalyptus oilEugenolGlycol salicylateHexylresorcinolHistamine dihydrochlorideMenthol (exceeding 1 percent)Methapyrilene hydrochlorideMethyl nicotinateMethyl salicylatePectinSalicylamideStrong ammonia solutionTannic acidThymolTripelennamine hydrochlorideTrolamine salicylateTurpentine oilZinc sulfate
(vi) Insect bite and sting drug products. AlcoholAlcohol, ethoxylated alkylBenzalkonium chlorideCalamineErgot fluidextractFerric chloridePanthenolPeppermint oilPyrilamine maleateSodium borateTrolamine salicylateTurpentine oilZinc oxideZirconium oxide
(vii) Poison ivy, poison oak, and poison sumac drug products. AlcoholAspirinBenzethonium chlorideBenzocaine (0.5 to 1.25 percent)BithionolCalamineCetalkonium chlorideChloral hydrateChlorobutanolChlorpheniramine maleateCreosote, beechwoodCyclomethycaine sulfateDexpanthenolDiperodon hydrochlorideEucalyptus oilEugenolGlycerinGlycol salicylateHectoriteHexylresorcinolHydrogen peroxideImpatiens biflora tinctureIron oxideIsopropyl alcoholLanolinLead acetateMerbrominMercuric chlorideMethapyrilene hydrochloridePanthenolParethoxycaine hydrochloridePhenyltoloxamine dihydrogen citratePovidone-vinylacetate copolymersPyrilamine maleateSalicylamideSalicylic acidSimethiconeSulfurTannic acidThymolTrolamine salicylateTurpentine oilZirconium oxideZyloxin
(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.
(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. AloinBile salts/acidsCalcium pantothenateCalomelColocynthElaterin resinFrangulaGambogeIpomeaJalapOx bilePodophyllum resinPrune concentrate dehydratePrune powderRhubarb, ChineseSodium Oleate
(A) Stimulant laxatives--Approved as of May 7, 1991. AloinBile salts/acidsCalcium pantothenateCalomelColocynthElaterin resinFrangulaGambogeIpomeaJalapOx bilePodophyllum resinPrune concentrate dehydratePrune powderRhubarb, ChineseSodium Oleate
(iv)(B) Stimulant laxatives--Approved as of January 29, 1999. DanthronPhenolphthalein
(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 CamphorCresolDibucaineDibucaine hydrochlorideEucalyptolLidocaineLidocaine hydrochlorideMethly salicylateMyrrh tincturePyrilamine maleateSorbitolSugarsTetracaineTetracaine hydrochlorideThymol
(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
(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 fluidextractIpecac tinctureZinc 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)
(i)(A) Ingredients--Approved as of May 7, 1991. Allantoin (wound healing claims only)SulfurTannic acidZinc acetate (wound healing claims only)
(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. AcetoneAlcoholAlum, ammoniumAlum, potassiumAluminum chlorhydroxy complexAromaticsBenzalkonium chlorideBenzethonium chlorideBenzocaineBenzoic acidBoric acidCalcium acetate (except calcium acetate monohydrate when combined with aluminum sulfate tetradecahydrate to provide an aluminum acetate solution as described in Sec. 347.20(b) of this chapter)Camphor gumClove oilColloidal oatmealCresolCupric sulfateEucalyptus oilEugenolFerric subsulfate (Monsel's Solution)HoneyIsopropyl alcoholMentholMethyl salicylateOxyquinoline sulfateP-t-butyl-m-cresolPeppermint oilPhenolPolyoxeythylene lauratePotassium ferrocyanideSage oilSilver nitrateSodium borateSodium diacetateTalcTannic acid glyceriteThymolTopical starchZinc chlorideZinc oxideZinc phenolsulfonateZinc stearateZinc sulfate
(iii) Diaper rash drug products. Aluminum hydroxideCocoa butterCysteine hydrochlorideGlycerinProtein hydrolysateRacemethionineSulfurTannic acidZinc acetateZinc carbonate
(iv) Fever blister and cold sore treatment drug products. Bismuth subnitrateBoric acidPyridoxine hydrochlorideSulfurTannic acidTopical starchTrolamineZinc 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
(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
(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
(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.
(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. AlcloxaAlum, potassiumAluminum sulfateAmyltricresols, secondaryBasic fuchsinBenzethonium chlorideBenzoic acidBenzoxiquineBoric acidCamphorCandicidinChlorothymolCoal tarDichlorophenMentholMethylparabenOxyquinolineOxyquinoline sulfatePhenolPhenolate sodiumPhenyl salicylatePropionic acidPropylparabenResorcinolSalicylic acidSodium borateSodium caprylateSodium propionateSulfur Tannic acidThymolTolindateTriacetinZinc caprylateZinc propionate
(iii) Any ingredient(s) labeled with claims or directions for use on the scalp or on the nails.
(iv) Ingredients. Camphorated metacresolChloroxylenolm-cresolNystatin
(23) Internal analgesic drug products--(i) Approved as of November 10, 1993. Aminobenzoic acidAntipyrineAspirin, aluminumCalcium salicylateCodeineCodeine phosphateCodeine sulfateIodoantipyrineLysine aspirinMethapyrilene fumaratePhenacetinPheniramine maleatePyrilamine maleateQuinineSalsalateSodium aminobenzoate
(i) Approved as of November 10, 1993. Aminobenzoic acidAntipyrineAspirin, aluminumCalcium salicylateCodeineCodeine phosphateCodeine sulfateIodoantipyrineLysine aspirinMethapyrilene fumaratePhenacetinPheniramine maleatePyrilamine maleateQuinineSalsalateSodium 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. AlcoholAlfalfa leavesAloesAsclepias tuberosaAsparagusBarosmaBearberry (extract of uva ursi)Bearberry fluidextract (extract of bearberry)Blessed thistle (cnicus benedictus)Buchu powdered extract (extract of buchu)Calcium lactateCalcium pantothenateCapsicum oleoresinCascara fluidextract, aromatic (extract of cascara)Chlorprophenpyridamine maleateCimicifuga racemosaCodeineCollinsonia (extract stone root)Corn silkCouch grassDog grass extractEthyl nitriteFerric chlorideFerrous sulfateGentiana lutea (gentian)Glycyrrhiza (licorice)Homatropine methylbromideHydrangea, powdered extract (extract of hydrangea)Hydrastis canadensis (golden seal)Hyoscyamine sulfateJuniper oil (oil of juniper)Magnesium sulfateMethapyrilene hydrochlorideMethenamineMethylene blueNatural estrogenic hormoneNiacinamideNutmeg oil (oil of nutmeg)Oil of erigeronParsleyPeppermint spiritPepsin, essencePhenacetinPhenindamine tartratePhenyl salicylatePiscidia erythrinaPipsissewaPotassium acetatePotassium nitrateRiboflavinSaw palmettoSenecio aureusSodium benzoateSodium nitrateSucroseSulferated oils of turpentineTaraxacum officinaleTheobromine sodium salicylateTheophyllineThiamine hydrochlorideTriticumTurpentine, venice (venice turpertine)Urea
(i) Approved as of November 10, 1993. AlcoholAlfalfa leavesAloesAsclepias tuberosaAsparagusBarosmaBearberry (extract of uva ursi)Bearberry fluidextract (extract of bearberry)Blessed thistle (cnicus benedictus)Buchu powdered extract (extract of buchu)Calcium lactateCalcium pantothenateCapsicum oleoresinCascara fluidextract, aromatic (extract of cascara)Chlorprophenpyridamine maleateCimicifuga racemosaCodeineCollinsonia (extract stone root)Corn silkCouch grassDog grass extractEthyl nitriteFerric chlorideFerrous sulfateGentiana lutea (gentian)Glycyrrhiza (licorice)Homatropine methylbromideHydrangea, powdered extract (extract of hydrangea)Hydrastis canadensis (golden seal)Hyoscyamine sulfateJuniper oil (oil of juniper)Magnesium sulfateMethapyrilene hydrochlorideMethenamineMethylene blueNatural estrogenic hormoneNiacinamideNutmeg oil (oil of nutmeg)Oil of erigeronParsleyPeppermint spiritPepsin, essencePhenacetinPhenindamine tartratePhenyl salicylatePiscidia erythrinaPipsissewaPotassium acetatePotassium nitrateRiboflavinSaw palmettoSenecio aureusSodium benzoateSodium nitrateSucroseSulferated oils of turpentineTaraxacum officinaleTheobromine sodium salicylateTheophyllineThiamine hydrochlorideTriticumTurpentine, 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. BenzocaineBenzyl alcoholBenzyl benzoateChlorophenothane (dichlorodiphenyl trichloroethane)Coconut oil soap, aqueousCopper oleateDocusate sodiumFormic acidIsobornyl thiocyanoacetatePicrotoxinPropylene glycolSabadilla alkaloidsSulfur, sublimedThiocyanoacetate
(i) Approved as of November 10, 1993. BenzocaineBenzyl alcoholBenzyl benzoateChlorophenothane (dichlorodiphenyl trichloroethane)Coconut oil soap, aqueousCopper oleateDocusate sodiumFormic acidIsobornyl thiocyanoacetatePicrotoxinPropylene glycolSabadilla alkaloidsSulfur, sublimedThiocyanoacetate
(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
(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
(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
(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
(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
(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)(39) 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 Sec. 358.710(a)(1) of this chapter. This section does not apply to products allowed by Sec. 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 Sec. 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. [55 FR 46919, Nov. 7, 1990]
Editorial Note: For Federal Register citations affecting Sec. 310.545, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
Effective Date Note: At 61 FR 9571, Mar. 8, 1996, in Sec. 310.545 in paragraph (a)(6)(ii)(B), the entry for ``l-desoxyephedrine (topical)'' was stayed until further notice.