Label: PERSONAL CARE ANTIBACTERIAL FOAMING HAND WASH- triclosan liquid

  • 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 August 10, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient                              Purpose

    Triclosan 0.4%                          Antibacterial

  • 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 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.

  • DOSAGE & ADMINISTRATION

    Directions

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

    Inactive Ingredients

    water (aqua), ammonium laryl sulfate,  coconut oil, diethanolamide, sodium fatty alcohol ether sulfate, citric acid, kathon CG, Fragrance, Red #33, Yellow#5

  • DESCRIPTION

    Protects your family better compared to ordinary liquid hand soap.

    Manufactured in China

    Exclusively for and Distributed by:

    Personal Care Products, Inc.

    Bingham Farms, MI 48025-2463


  • PRINCIPAL DISPLAY PANEL

    Personal  Care

    Antibacterial Foaming Hand wash
    Excellent germ kill
     
    7.5 fl oz (221ml)


  • PRINCIPAL DISPLAY PANEL

    Antibac Foaming Hand Wash PDP

  • PRINCIPAL DISPLAY PANEL

    Antibac Foaming Handwash panel

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE ANTIBACTERIAL FOAMING HAND WASH 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-0881
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    DIETHANOLAMINE (UNII: AZE05TDV2V)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHER (UNII: 0F5N573A2Y)  
    SULFATE ION (UNII: 7IS9N8KPMG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-0881-0221 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E01/07/2011
    Labeler - Personal Care Products, LLC (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co., Ltd528196956manufacture
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