Label: SUAVE REVITALIZING MINT AND EUCALYPTUS ANTIDANDRUFF CONDITIONER- pyrithione zinc suspension

  • 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 February 9, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (0.5%)

  • 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 (Aqua)
    Cetearyl Alcohol
    Cyclopentasiloxane
    Stearamidopropyl Dimethylamine
    Dimethiconol
    Behentrimonium Chloride
    Fragrance (Parfum)
    Dipropylene Glycol
    Lactic Acid
    DMDM Hydantoin
    Zinc Sulfate
    Sodium Chloride
    TEA-Dodecylbenzenesulfonate
    PEG-150 Distearate
    Helianthus Annuus (Sunflower) Seed Oil
    Tocopheryl Acetate
    Methylisothiazolinone
    Methylchloroisothiazolinone
    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
    Suave Mint and Eucalyptus AD Conditioner PDP
  • INGREDIENTS AND APPEARANCE
    SUAVE  REVITALIZING MINT AND EUCALYPTUS ANTIDANDRUFF CONDITIONER
    pyrithione zinc suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione - UNII:6GK82EC25D) Pyrithione Zinc0.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1236-1428 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/09/2012
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture
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