Label: ANTI-DANDRUFF- zinc pyrithione shampoo
- NDC Code(s): 83080-121-01, 83080-121-02
- Packager: MEERAY COSMETICS CO., LTD.
- 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 February 27, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Dosage and Administration
- Ask a doctor
- Do Not Use
-
Inactive Ingredients
Aqua (Deionized Water), Decyl Glucoside, Lauryl Glucoside, Coco Glucoside, Hydrolyzed Soy Protein, Guar Hydroxypropyltrimonium Chloride, Hydrolyzed Keratin, Tocopherol, Pantothenic Acid, Saccharomyces/Selenium Ferment, Calcium Chloride, Copper Gluconate, Potassium Chloride, Managanese Gluconate, Magnesium Gluconate, Zinc Gluconate, Sodium Chloride, Olea Europaea Fruit Oil, Myrtus Comunis Oil, Lavandula Angustifolia Oil, Thymus Vulgaris Oil, Rosmarinus Officinalis Leaf Oil, Prunus Armeniaca Kernal Oil, Eugenia Caryophyllus Flower Oil, Oryza Sativa Powder, Tapioca Starch, Carica Papayan Fruit, Yeast Extract, Rosmarinus Officinalis Leaf Powder, Salvia Officinalis Leaf Extract, Sucrose, Phenethyl Alcohol, Caprylyl Glycol, Citric Acid, Tetrasodium EDTA, Essential Oils Blend
- Indications
- Label Images
-
INGREDIENTS AND APPEARANCE
ANTI-DANDRUFF
zinc pyrithione shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83080-121 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 100 mL Inactive Ingredients Ingredient Name Strength SOYBEAN OIL (UNII: 241ATL177A) COCONUT OIL (UNII: Q9L0O73W7L) POTASSIUM CHLORIDE (UNII: 660YQ98I10) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) PANTOTHENIC ACID (UNII: 19F5HK2737) OLIVE OIL (UNII: 6UYK2W1W1E) WATER (UNII: 059QF0KO0R) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) YEAST (UNII: 3NY3SM6B8U) SODIUM HYDROXIDE (UNII: 55X04QC32I) DISODIUM 1-(LAURETH-2) SULFOSUCCINATE (UNII: 0A13NT4QUI) PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4) SODIUM CHLORIDE (UNII: 451W47IQ8X) 4-METHYLPHENETHYL ALCOHOL (UNII: GG36R9LNV8) STARCH, TAPIOCA (UNII: 24SC3U704I) CARICA PAPAYA WHOLE (UNII: S0U63B0Q51) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) SUCROSE (UNII: C151H8M554) TOCOPHEROL (UNII: R0ZB2556P8) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075) AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) MYRTUS COMMUNIS LEAF (UNII: U20N87188F) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) THYMUS VULGARIS LEAF (UNII: GRX3499643) BETA CAROTENE (UNII: 01YAE03M7J) SAFFLOWER (UNII: 4VBL71TY4Y) SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN) CITRIC ACID ACETATE (UNII: DSO12WL7AU) PROPANEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) COPPER GLUCONATE (UNII: RV823G6G67) SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD) MANGANESE GLUCONATE (UNII: 9YY2F980SV) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) ORANGE PEEL (UNII: TI9T76XD44) PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N) CLOVE LEAF OIL (UNII: VCA5491KVF) CLIMBAZOLE (UNII: 9N42CW7I54) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83080-121-01 300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2023 2 NDC:83080-121-02 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 03/01/2023 Labeler - MEERAY COSMETICS CO., LTD. (688311376)
