Label: CLEAR COMPLETE CARE NOURISHING 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 April 9, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (1.0%)

  • PURPOSE

    PurposeAntidandruff

  • INDICATIONS & USAGE

    Use Helps prevent and control recurrence of itching and flaking associated with 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 as directed.

    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

    Wet hair, massage into scalp, rinse.  Repeat if desired.  For best results use at least twice a week or as directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive IngredientsWater (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Fragrance (Parfum), Dimethiconol, Sodium Chloride, Sodium Lauroyl Isethionate, Carbomer, Dimethicone, Stearic Acid, Sodium Isethionate, DMDM Hydantoin, Hydrogenated Coconut Oil, Guar Hydroxypropyltrimonium Chloride, Citric Acid, Glycerin, Zinc Sulfate, TEA-Dodecylbenzenesulfonate, Tallow Acid, Poloxamer 407, Laureth-23, Tocopheryl Acetate, Laureth-4, Lysine HCl, Panthenol, PPG-9, Butylene Glycol, Iodopropynyl Butylcarbamate, PEG-4, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glycine Soja (Soybean) Oil, Methylchloroisothiazolinone, Methylisothiazolinone, Aloe Barbadensis Leaf Extract, Ascorbic Acid, Niacinamide, Titanium Dioxide (CI 77891)

  • QUESTIONS

    Questions or comments?

    1-800-372-6389

  • PDP 12.9 fl oz

    ClearConpleteCareNourishingADPDP

  • PDP back 12.9 fl oz

    ClearConpleteCareNourishingADback

  • INGREDIENTS AND APPEARANCE
    CLEAR  COMPLETE CARE NOURISHING ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1356
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAUROYL ISETHIONATE (UNII: M590021Z02)  
    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)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    LAURETH-23 (UNII: N72LMW566G)  
    LAURETH-4 (UNII: 6HQ855798J)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    POLYETHYLENE GLYCOL 400000 (UNII: 439X29GCJZ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TALLOW ACID, BEEF (UNII: 5U9XZ261ER)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1356-1381 mL in 1 CONTAINER
    2NDC:64942-1356-289 mL in 1 CONTAINER
    3NDC:64942-1356-350 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/13/2014
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture(64942-1356)