Label: CLEAR COMPLETE SCALP CARE ANTIDANDRUFF CONDITIONER- pyrithione zinc suspension

  • Category: HUMAN OTC DRUG LABEL

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 22, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (0.5%)

  • PURPOSE

    PurposeAnti-dandruff

  • INDICATIONS & USAGE

    Use: Fights the symptoms of dandruff

  • WARNINGS

    Warnings
    For external use only

    When using this product: Avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if: Condition worsens or does not improve after regular use of this product.

    Keep this and all drugs out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Massage into scalp & hair. Rinse. For best results use at least twice a week or as directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (Aqua), Cetearyl Alcohol, Cyclopentasiloxane, Stearamidopropyl Dimethylamine, Dimethiconol, Behentrimonium Chloride, Fragrance (Parfum), Dipropylene Glycol, Lactic Acid, DMDM Hydantoin, Zinc Sulfate, Sodium Chloride, TEA-Dodecylbenzenesulfonate, Elaeis Guineensis (Palm) Oil, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Juice, Glycerin, Butylene Glycol, Iodopropynyl Butylcarbamate, Glycine Soja (Soybean) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Methylisothiazolinone, Ascorbic Acid, Panthenol, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Methylchloroisothiazolinone, Biotin, Niacinamide.

  • QUESTIONS

    Questions, comments?

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  • 12.7 fl oz PDP

    ClearCompleteScalpCareAntidandruffConditionerPDP

  • INGREDIENTS AND APPEARANCE
    CLEAR  COMPLETE SCALP CARE ANTIDANDRUFF CONDITIONER
    pyrithione zinc suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1435
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PALM OIL (UNII: 5QUO05548Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BIOTIN (UNII: 6SO6U10H04)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1435-1375 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/15/2015
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture(64942-1435)
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