Label: PREVAIL WHITE TEA SCENTED ANTIBACTERIAL HAND- triclosan soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 25, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Triclosan  0.15%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use   For hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

    For external use only.

    Do not use in eyes. If contact occurs, flush eyes.

    Stop use and ask a doctor if irritation and redness develop.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions      Pump soap onto wet hands, lather, rinse thoroughly.

  • INACTIVE INGREDIENT

    Inactive ingredients    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycerin, DMDM Hydantoin, Peg-7 Glyceryl Cocoate, Polyquaternium-7, Fragrance, Hydrolyzed Silk, Tetrasodium EDTA, Citric Acid, FDandC Blue 1, DandC Red No.33

  • SPL UNCLASSIFIED SECTION

    100% Guaranteed   DIST. BY DUANE READE

    (866)375-6925/440 Ninth Ave, NY, NY 10001

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    Prevail

    white tea

    scented


    antibacterial
    hand soap

    8.5 FL. OZ (250 mL)
  • PRINCIPAL DISPLAY PANEL

    HandSoap250mL

  • INGREDIENTS AND APPEARANCE
    PREVAIL WHITE TEA SCENTED ANTIBACTERIAL HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-100-080.250 L in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/23/2011
    Labeler - Duane Reade (011988995)
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