Label: HAND ANTIBACTERIAL PREMIUM- 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 March 30, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Triclosan 0.2%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses for hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings For external use only.

  • WHEN USING

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

  • STOP USE

    Stop use and ask  doctor if irritation and redness develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION


    Directions

    • pump into hands
    • lather vigorously for at least 15 seconds
    • rinse and dry thoroughly

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Chloride, Lauramide DEA, DMDM Hydantoin, Fragrance, Citric Acid, Tatrasodium EDTA, FD and C Yellow No. 5, FD and C Red No. 40.

  • PRINCIPAL DISPLAY PANEL

    DAY2DAY

    Liquid

    Hand Soap

    Antibacterial

    Premium



    16 FL OZ (472ml)



    HandSoap

  • INGREDIENTS AND APPEARANCE
    HAND ANTIBACTERIAL PREMIUM 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76088-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76088-200-16472 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/02/2011
    Labeler - King Import Warehouse (805424678)
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