Label: KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF- pyrithione zinc lotion

  • NDC Code(s): 63766-003-01, 63766-003-02, 63766-003-03
  • Packager: Avlon Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 29, 2024

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  • Active Ingredient

    Pyrithione Zinc 1%

  • Purpose

    Anti-Dandruff, Anti-Seborrheic Dermatitis

  • INDICATIONS & USAGE

    Use for the relief of scalp flaking, itching and irritation associated with

    dandruff and seborrheic dermatitis.

  • Warnings

    ■ For external use only

    -----------------------------------------------------------------------------------------------------

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ seborrheic dermatitis that covers large areas of your body.

    -----------------------------------------------------------------------------------------------------

  • WHEN USING

    When using this product

    ■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

    ■ Use caution in exposing skin to sunlight after applying this product. It may

    increase your tendency to sunburn for up to 24 hours after application.

    -----------------------------------------------------------------------------------------------------

  • STOP USE

    Stop use and ask a doctor if

    ■ Condition worsens or does not improve with regular use.

    -----------------------------------------------------------------------------------------------------

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact

    a Poison Control Center right away.

  • Directions

    For best results, shampoo first with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing
    Shampoo. Distribute KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner
    throughout hair and cover with a plastic cap. Leave on a few minutes and rinse thoroughly. Style
    as usual.

  • Inactive Ingredients

    Aqua/Water/Eau, Cocos Nucifera (Coconut) Oil, Betaine, Aloe Barbadensis Leaf Juice, Cetearyl
    Alcohol, Cetyl Alcohol, Glycerin, Stearamidopropyl Dimethylamine, Behentrimonium Chloride,
    Linum Usitatissimum (Linseed) Seed Extract, Quaternium-80, Piroctone Olamine, Menthol,
    Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6,
    Fragrance/Parfum, Polyquaternium-10, Dipropylene Glycol, Propanediol, Caprylyl Glycol,
    Phenoxyethanol, Citric Acid, Polyacrylamide, Benzyl Salicylate, Hexyl Cinnamal, Linalool.

  • PRINCIPAL DISPLAY PANEL

    KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner

    Product NDC 63766-003

    Label

  • INGREDIENTS AND APPEARANCE
    KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-003
    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
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BETAINE (UNII: 3SCV180C9W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    FLAX SEED (UNII: 4110YT348C)  
    2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID (UNII: 71X53V3RZ1)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63766-003-01240 mL in 1 TUBE; Type 0: Not a Combination Product06/18/2009
    2NDC:63766-003-02950 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2009
    3NDC:63766-003-0315 mL in 1 POUCH; Type 0: Not a Combination Product06/18/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/18/2009
    Labeler - Avlon Industries, Inc. (121278626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avlon Industries, Inc.121278626manufacture(63766-003)
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