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
  • 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 11, 2020

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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

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  • 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 finalpart358H06/18/2009
    Labeler - Avlon Industries, Inc. (121278626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avlon Industries, Inc.121278626manufacture(63766-003)
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