Label: AFFIRMCARE SCALP THERAPY HYDRATING ANTI-DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 63766-300-01, 63766-300-02, 63766-300-72
- Packager: Avlon Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 16, 2022
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- Active Ingredient
- Purpose
- Uses
- Warnings
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Inactive Ingredient
Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium
Laureth Sulfosuccinate, Betaine, Cocamidopropyl Betaine,
Cocamide MIPA, Sodium Cocoyl Isethionate, Cetyl Alcohol,
Melia Azadirachta Seed Oil, Origanum Vulgare Leaf Extract,
Linum Usitatissimum (Linseed) Seed Extract, Camellia
Sinensis Leaf Extract, Menthol, Keratin, Hydrolyzed Keratin,
Glycol Stearate, Glycerin, Piroctone Olamine, Phenoxyethanol,
Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum,
Tetrasodium EDTA, Ceteareth-60 Myristyl Glycol,
Quaternium-80, Polyquaternium-10, Propanediol, Benzyl
Benzoate, Limonene, Hexyl Cinnamal. - QUESTIONS
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INGREDIENTS AND APPEARANCE
AFFIRMCARE SCALP THERAPY HYDRATING ANTI-DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63766-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL BENZOATE (UNII: N863NB338G) WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) LINSEED OIL (UNII: 84XB4DV00W) GLYCOL STEARATE (UNII: 0324G66D0E) POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPANEDIOL (UNII: 5965N8W85T) OREGANO (UNII: 0E5AT8T16U) GREEN TEA LEAF (UNII: W2ZU1RY8B0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) BETAINE (UNII: 3SCV180C9W) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) CETYL ALCOHOL (UNII: 936JST6JCN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MENTHOL (UNII: L7T10EIP3A) CETEARETH-60 MYRISTYL GLYCOL (UNII: 4O832ZOY6W) EDETATE SODIUM (UNII: MP1J8420LU) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) CAPRYLIC ACID (UNII: OBL58JN025) HYDROLYZED SHEEP WOOL KERATIN (2000 MW) (UNII: NZR037QF7Z) AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) 2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID (UNII: 71X53V3RZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63766-300-01 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 09/13/2018 2 NDC:63766-300-02 950 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2018 3 NDC:63766-300-72 240 mL in 1 TUBE; Type 0: Not a Combination Product 09/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/12/2018 Labeler - Avlon Industries, Inc. (121278626) Establishment Name Address ID/FEI Business Operations Avlon Industries Inc 121278626 manufacture(63766-300)