Label: REDKEN BREWS NYC GROOMING PYRITHIONE ZINC ANTI-DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 49967-183-01, 49967-183-02, 49967-183-03
  • Packager: L'Oreal USA Products 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 September 7, 2018

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Pyrithione Zinc 1%

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  • Purpose

    Anti-dandruff

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  • Uses

    • for the relief of the symptoms of dandruff
    • helps prevent recurrence of the symptoms of dandruff
    • controls scalp itching, irritation, redness, flaking, and scaling associated with dandruff
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  • Warnings

    For external use only

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  • Ask a doctor before use

    in children under 2 years of age

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  • When using this product

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

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  • Stop use and ask a physician if

    condition worsens or does not improve after regular use

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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • for best results, use at least twice a week or as directed by a doctor
    • shake well before each use
    • wet hair and apply a small amount of shampoo
    • apply evely to scalp, leave on for several minutes, and then rinse off
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  • Inactive ingredients

    water, sodium laureth sulfate, sodium lauryl sulfate, glycerin, cocamide MEA, glycol distearate, sodium chloride, hexylene glycol, dimethicone, citric acid, fragrance, sodium benzoate, sodium hydroxide, coco-betaine, carbomer, guar hydroxypropyltrimonium chloride, menthoxypropanediolm sodium polynaphthalenesulfonate, salicylic acid, hydrolyzed soy protein, eugenol, limonene, cellulose gum, lecithin, fumaric acid, phosphoric acid, lavandula angustifolia (lavender) oil, methylisothiazolinone

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  • INGREDIENTS AND APPEARANCE
    REDKEN BREWS NYC GROOMING PYRITHIONE ZINC ANTI-DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-183
    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
    water (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    sodium benzoate (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    EUGENOL (UNII: 3T8H1794QW)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED form (UNII: K679OBS311)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FUMARIC ACID (UNII: 88XHZ13131)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49967-183-01 300 mL in 1 TUBE; Type 0: Not a Combination Product 07/02/2018
    2 NDC:49967-183-02 1000 mL in 1 TUBE; Type 0: Not a Combination Product 07/02/2018
    3 NDC:49967-183-03 50 mL in 1 TUBE; Type 0: Not a Combination Product 07/02/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 07/02/2018
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    Name Address ID/FEI Business Operations
    L'OREAL USA, INC. 960317444 manufacture(49967-183) , pack(49967-183)
    Establishment
    Name Address ID/FEI Business Operations
    Universal Packaging Systems Inc. 078717086 pack(49967-183)
    Establishment
    Name Address ID/FEI Business Operations
    Unette Corporation 011401882 pack(49967-183)
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