Label: SUAVE PROFESSIONALS MEN 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 7, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (1.0%)

  • PURPOSE

    Purpose
    Antidandruff
  • INDICATIONS & USAGE

    Use controls scalp 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 out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    ·  wet hair, lather, rinse, and repeat.
    ·  for best results, use at least twice a week or as directed by a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water
    Sodium Laureth Sulfate
    Cocamidopropyl Betaine
    Sodium Chloride
    Carbomer
    Fragrance
    Dimethiconol
    Glycol Distearate
    DMDM Hydantoin
    Guar Hydroxypropyltrimonium Chloride
    TEA-Dodecylbenzenesulfonate
     Iodopropynyl Butylcarbamate
    Citric Acid
    PPG-9
    Methylchloroisothiazolinone
    Methylisothiazolinone
    Blue 1 (CI 42090)
  • QUESTIONS

    Questions/Comments?

    call us at 1-800-782-8301 Mon - Fri 8:30 - 6:00 pm EST
  • PRINCIPAL DISPLAY PANEL

    PDP back
    Suave Men AD shampoo back
  • PRINCIPAL DISPLAY PANEL

    14.5 oz front
    Suave Men AD Shampoo front
  • INGREDIENTS AND APPEARANCE
    SUAVE  PROFESSIONALS MEN ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1130
    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)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PPG-9 (UNII: I29VQH0G0B)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1130-1429 mL in 1 CONTAINER
    2NDC:64942-1130-2373 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/08/2010
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture
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