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

  • NDC Code(s): 63766-002-01, 63766-002-02, 63766-002-03
  • 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

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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.

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  • STOP USE

    Stop use and ask a doctor if

    ■ Condition worsens or does not improve with regular use.

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  • 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

    • Apply to wet hair and gently lather with fingertips. Rinse and repeat. Leave on 5 minutes. Shampoo with KeraCare® Hydrating Detangling Shampoo for a final sudsing. For best results, follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner.
  • Inactive Ingredients

    Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium Laureth Sulfosuccinate,

    Cocamidopropyl Betaine, Cocamide MIPA, Polysorbate 20, Sodium Cocoyl

    Isethionate, Cetyl Alcohol, Glycerin, Menthol, Piroctone Olamine, Pyrus Malus

    (Apple) Fruit Extract, Citrus Limon (Lemon) Peel Extract , Camellia Sinensis Leaf

    Extract, Fragrance/Parfum, Quaternium-80, Propanediol, Polyquaternium-10,

    Caprylyl Glycol, Phenoxyethanol, Tetrasodium EDTA, Citric Acid, Benzyl Salicylate,

    Hexyl Cinnamal, Linalool, Blue 1 (CI 42090).

  • PRINCIPAL DISPLAY PANEL

    KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo

    Product NDC

    63766-002

    Label

  • INGREDIENTS AND APPEARANCE
    KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-002
    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
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    APPLE (UNII: B423VGH5S9)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    MENTHOL (UNII: L7T10EIP3A)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    LEMON PEEL (UNII: 72O054U628)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID (UNII: 71X53V3RZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63766-002-01240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2009
    2NDC:63766-002-02950 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2009
    3NDC:63766-002-0315 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(63766-002)
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