Label: DANDRUFF- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 46607-112-01, 46607-112-02 - Packager: Ecocare
- 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 April 7, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Dosage and Administration
- Other Information
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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
- Do Not Use
- Ask a doctor
- Directions
- image of label
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INGREDIENTS AND APPEARANCE
DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46607-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10.0 mg in 100 mL Inactive Ingredients Ingredient Name Strength DISODIUM 1-(LAURETH-2) SULFOSUCCINATE (UNII: 0A13NT4QUI) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) TOCOPHEROL (UNII: R0ZB2556P8) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PANTOTHENIC ACID (UNII: 19F5HK2737) SOYBEAN OIL (UNII: 241ATL177A) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) COCONUT OIL (UNII: Q9L0O73W7L) COPPER GLUCONATE (UNII: RV823G6G67) OLIVE OIL (UNII: 6UYK2W1W1E) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD) MANGANESE GLUCONATE (UNII: 9YY2F980SV) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) SODIUM CHLORIDE (UNII: 451W47IQ8X) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) MYRTUS COMMUNIS LEAF (UNII: U20N87188F) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ORANGE PEEL (UNII: TI9T76XD44) THYMUS VULGARIS LEAF (UNII: GRX3499643) BETA CAROTENE (UNII: 01YAE03M7J) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) SAFFLOWER (UNII: 4VBL71TY4Y) PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N) 4-METHYLPHENETHYL ALCOHOL (UNII: GG36R9LNV8) CLOVE LEAF OIL (UNII: VCA5491KVF) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) CLIMBAZOLE (UNII: 9N42CW7I54) STARCH, TAPIOCA (UNII: 24SC3U704I) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) CARICA PAPAYA WHOLE (UNII: S0U63B0Q51) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) YEAST (UNII: 3NY3SM6B8U) sodium hydroxide (UNII: 55X04QC32I) ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O) SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN) SUCROSE (UNII: C151H8M554) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID ACETATE (UNII: DSO12WL7AU) TRIMETHYLENEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46607-112-01 300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/29/2017 2 NDC:46607-112-02 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/29/2017 Labeler - Ecocare (785638821)