Label: CLEAR COMPLETE SCALP CARE ANTIDANDRUFF- pyrithione zinc shampoo

  • 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 17, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (1.0%)

  • PURPOSE

    Purpose

    Anti-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), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Dimethiconol, Fragrance (Parfum), Carbomer, Dimethicone, DMDM Hydantoin, Guar Hydroxypropyltrimonium Chloride, Citric Acid, Glycerin, Zinc Sulfate, TEA-Dodecylbenzenesulfonate, Poloxamer 407, Laureth-23, Laureth-4, Elaeis Guineensis (Palm) Oil, Helianthus Annuus (Sunflower) Seed Oil, PPG-9, Aloe Barbadensis Leaf Juice, Butylene Glycol, Iodopropynyl Butylcarbamate, PEG-4, Xanthan Gum, Glycine Soja (Soybean) Oil, Methylchloroisothiazolinone, Cucumis Sativus (Cucumber) Fruit Extract, Methylisothiazolinone, Ascorbic Acid, Panthenol, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Disodium EDTA, Biotin, Niacinamide

  • QUESTIONS

    Questions, comments?1-800-372-6389

  • 12.9 oz PDP

    ClearCompleteScalpCareADShampooPDP

  • INGREDIENTS AND APPEARANCE
    CLEAR  COMPLETE SCALP CARE ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1434
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc1.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PPG-9 (UNII: I29VQH0G0B)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    LAURETH-23 (UNII: N72LMW566G)  
    LAURETH-4 (UNII: 6HQ855798J)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PALM OIL (UNII: 5QUO05548Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    BIOTIN (UNII: 6SO6U10H04)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1434-1647 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:64942-1434-2381 mL in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:64942-1434-350 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(64942-1434)