Label: POWERHOUSE FRESH SCENT ULTRA DISH- 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 December 29, 2011

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  • ACTIVE INGREDIENT



    Active Ingredient

    Triclosan  0.10%

  • PURPOSE



    Purpose

    Antibacterial Hand Soap

  • KEEP OUT OF REACH OF CHILDREN



    Keep out of reach of children

    In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

  • INDICATIONS & USAGE



    Use

    Helps fights germs on hands when used as a hand soap.

  • WARNINGS



    Warning

    For external use only

  • DOSAGE & ADMINISTRATION



    Directions

    Wash hands and rinse.

  • INACTIVE INGREDIENT


    Inactive Ingredients:


  • PRINCIPAL DISPLAY PANEL

    label

    Powerhouse Fresh Scent Ultra Dish Detergent Antibacterial Hand Soap

    19 fl oz.

    (1 pt.3 oz) 562 ml

  • INGREDIENTS AND APPEARANCE
    POWERHOUSE FRESH SCENT ULTRA DISH 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.562 mL  in 562 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9087-2562 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/19/2011
    Labeler - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co Ltd528196956manufacture