Label: DANDRUFF- pyrithione zinc shampoo

  • 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

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  • ACTIVE INGREDIENT

    Active Ingredients                                                               Purpose

    Zinc Pyrithione 0.95%..............................................................Anti-Dandruff

  • Purpose

    Uses: Helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    FOR EXTERNAL USE ONLY

  • When using this product

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

  • Keep out of reach of children

    Keep out of reach of children.

  • Dosage and Administration

    • Shake well.
    • Wet hair thoroughly.
    • Massage a liberal quantity of shampoo evenly onto the scalp and rinse. Repeat and allow to remain on the scalp for a few minutes.
    • Rinse throroughly.
    • For best results use at least twice a week or as directed by a doctor.
  • Other Information

    For external use only

  • 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

    Helps prevent recurrance of flaking and itching associated with dandruff.

  • Do Not Use

    • Condition worsens or does not improve after regular use of this product as directed.
  • Ask a doctor

    • Condition worsens or does not improve after regular use of this product as directed.
  • Directions

    • Shake well.
    • Wet hair thoroughly.
    • Massage a liberal quantity of shampoo evenly onto the scalp and rinse. Repeat and allow to remain on the scalp for a few minutes.
    • Rinse thoroughly.
    • For best results use at least twice a week or as directed by a doctor.
  • image of label

    image of label

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46607-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10.0 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46607-112-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/29/2017
    2NDC:46607-112-021000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/29/2017
    Labeler - Ecocare (785638821)
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