Label: BERKLEY JENSEN HYPOALLERGENIC ANTIBACTERIAL HAND SOAP SOAP ENRICHED WITH VITAMIN E AND ALOE VERA MOISTURIZERS- triclosan solution

  • 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 January 22, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient - TRICLOSAN 0.15%

    Purpose -   Antibacterial

  • PURPOSE

    Uses - For handwashing 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 a 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.

  • SPL UNCLASSIFIED SECTION

    Directions:  Pump into hands, wet as needed.  Lather vigorously for at lest 15 seconds. Wash skin, rinse thoroughly and dry.

  • INACTIVE INGREDIENT


    Inactive Ingredients:  Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Sodium Chloride, Tocopheryl Acetate, Cocamide MEA, Fragrance, PEG-120 Methyl Glucose Dioleate, PEG-18, Glyceryl Oleate/Cocate Aloe Barbadensis Leaf Juice, Polyquaternium-7, DMDM Hydantoin, Tetrasodium EDTA, Citric Acid, Red 33, Blue1

  • PRINCIPAL DISPLAY PANEL

    BJ 3780

  • INGREDIENTS AND APPEARANCE
    BERKLEY JENSEN HYPOALLERGENIC ANTIBACTERIAL HAND SOAP SOAP  ENRICHED WITH VITAMIN E AND ALOE VERA MOISTURIZERS
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54340-764
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54340-764-013780 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2009
    Labeler - The Dial Corporation (070252531)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Dial Corporation, West Hazelton825091622manufacture
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