Label: REDKEN 5TH AVENUE NYC SCALP RELIEF DANDRUFF CONTROL- pyrithione zinc shampoo

  • NDC Code(s): 49967-795-01, 49967-795-02, 49967-795-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Antidandruff

  • 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
  • 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 physician if

    condition worsens or does not improve after regular use

  • Keep out of reach of children.

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

  • Directions

    • for best results use at least twice a week or as directed by a physician
    • shake well before each use
    • apply to wet or dry hair, massaging into scalp
    • leave on 5 minutes
    • wet hair, lather and rinse
    • can be used daily
  • 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, menthoxypropanediol, sodium polynaphthalenesulfonate, salicylic acid, hydrolyzed soy protein, eugenol, limonene, cellulose gum, lecithin, fumaric acid, phosphoric acid, lavandula angustifolia (lavender) oil, methylisothiazolinone, tocopherol

  • PRINCIPAL DISPLAY PANEL

    image of front label

    image of front label
  • PRINCIPAL DISPLAY PANEL

    image description
  • INGREDIENTS AND APPEARANCE
    REDKEN 5TH AVENUE NYC SCALP RELIEF DANDRUFF CONTROL 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-795
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (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: GFD7C86Q1W)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    FUMARIC ACID (UNII: 88XHZ13131)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-795-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/200608/01/2022
    2NDC:49967-795-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/13/202012/30/2021
    3NDC:49967-795-03250 mL in 1 TUBE; Type 0: Not a Combination Product10/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03208/17/2006
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC.960317444manufacture(49967-795)
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