Label: SUAVE REVITALIZING MINT AND EUCALYPTUS 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 December 22, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (1.0%)

  • PURPOSE

    Purpose
    Antidandruff
  • INDICATIONS & USAGE

    Uses: helps prevent recurrence of flaking and itching 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 onto 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
    Sodium Laureth Sulfate
    Cocamidopropyl Betaine
    Sodium Chloride
    Fragrance (Parfum)
    Carbomer
    Dimethiconol
    DMDM Hydantoin
    Citric Acid
    Guar Hydroxypropyltrimonium Chloride
    TEA-Dodecylbenzenesulfonate
    Butylene Glycol
    Iodopropynyl Butylcarbamate
    PPG-9
    Methylchloroisothiazolinone
    Methylisothiazolinone
    Mentha Viridis (Spearmint) Leaf Oil
    Eucalyptus Globulus Leaf Oil
    Yellow 5 (CI 19140)
    Blue 1 (CI 42090)
  • QUESTIONS

    Question (or comments)?: 1-800-782-8301

  • PRINCIPAL DISPLAY PANEL

    PDP front
    Suave Mint and Eucalyptus AD Shampoo front
  • PRINCIPAL DISPLAY PANEL

    back
    Suave Mint and Eucalyptus AD Shampoo back
  • INGREDIENTS AND APPEARANCE
    SUAVE  REVITALIZING MINT AND EUCALYPTUS ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1233
    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)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    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)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1233-1428 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/2012
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture
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