Label: CLEAR MEN STRONG AND FULL ANTIDANDRUFF- pyrithione zinc shampoo

  • 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 May 2, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (1.0%)

  • PURPOSE

    Purpose
    Antidandruff
  • INDICATIONS & USAGE

    Uses: 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
    Sodium Lauroyl Isethionate
    Helianthus Annuus (Sunflower) Seed Oil
    DMDM Hydantoin
    Guar Hydroxypropyltrimonium Chloride
    Stearic Acid
    Citric Acid
    Tallow Acid or Palmitic Acid
    Zinc Sulfate
    TEA-Dodecylbenzenesulfonate
    Sodium Isethionate
    Poloxamer 407
    Laureth-23
    Laureth-4
    Tocopheryl Acetate
    Prunus Amygdalus Dulcis (Sweet Almond) Oil
    PPG-9
    Panthenol
    Lysine HCl
    Hydrogenated Coconut Oil
    Glycine Soja (Soybean) Oil
    Methylisothiazolinone
    PEG-9M
    Xanthan Gum
    Methylchloroisothiazolinone
    Panax Ginseng Root Extract
    Mentha Viridis (Spearmint) Leaf Oil
    Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract
    Titanium Dioxide (CI 77891)
  • QUESTIONS

    Questions, comments?: 1-800-372-6389

  • PRINCIPAL DISPLAY PANEL

    PDP front
    Clear Men Strong and Full AD Shampoo front
  • PRINCIPAL DISPLAY PANEL

    back
    Clear Men Strong and Full AD Shampoo back
  • INGREDIENTS AND APPEARANCE
    CLEAR  MEN STRONG AND FULL ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1249
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione - UNII:6GK82EC25D) Pyrithione Zinc1.0 mL  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)  
    TEA-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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    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)  
    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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1249-1381 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/09/2012
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture
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