Label: CLEAR MEN 2 IN 1 COMPLETE 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 23, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (1.0%)

  • PURPOSE

    Purpose

    Anti-Dandruff

  • 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 Ingredients

    Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Fragrance (Parfum), Dimethiconol, Carbomer, Dimethicone, DMDM Hydantoin, Guar Hydroxypropyltrimonium Chloride, Citric Acid, Zinc Sulfate, TEA-Dodecylbenzenesulfonate, Poloxamer 407, Laureth-23, Butylene Glycol, Laureth-4, Lysine HCl, Tocopheryl Acetate, Panthenol, PPG-9, Iodopropynyl Butylcarbamate, PEG-4, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glycine Soja (Soybean) Oil, Cocos Nucifera (Coconut) Oil, Methylchloroisothiazolinone, Methylisothiazolinone, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Panax Ginseng Root Extract, Mentha Viridis (Spearmint) Leaf Oil.

  • QUESTIONS

    Questions, comments? 1-800-372-6389

  • 21.9 FL OZ

    ClearMenCC2in1ADPDP

  • PDP back

    ClearMenCC2in1ADPDPbackrev3

  • INGREDIENTS AND APPEARANCE
    CLEAR  MEN 2 IN 1 COMPLETE CARE ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    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)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    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)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    POLYETHYLENE GLYCOL 400000 (UNII: 439X29GCJZ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1269-1381 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:64942-1269-2975 mL in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:64942-1269-3647 mL in 1 CONTAINER; Type 0: Not a Combination Product
    4NDC:64942-1269-4476 mL in 1 CONTAINER; Type 0: Not a Combination Product
    5NDC:64942-1269-589 mL in 1 CONTAINER; Type 0: Not a Combination Product
    6NDC:64942-1269-650 mL in 1 CONTAINER; Type 0: Not a Combination Product
    7NDC:64942-1269-78.3 mL in 1 PACKET; 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(64942-1269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corp111359712manufacture(64942-1269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corp010765394manufacture(64942-1269)
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