Label: PERSONAL CARE 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 June 13, 2011

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  • Active Ingredient

    Triclosan 0.2%

  • Purpose

    Antibacterial

  • Uses

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

    When using this product

    Avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor

    if irritation and redness develops

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    pump into hands

    lather vigorously for at least 15 seconds

    rinse and dry thoroughly

  • Inactive Ingredients

    water (aqua), ammonium lauryl sulfate, ammonium chloride, lauramide DEA, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, yellow #5, red #40

  • PRINCIPAL DISPLAY PANEL

    Personal Care

    Antibacterial

    Washes Away Germs

    Soap
    7.5 fl oz
    (221ml)

    Distributed by Personal Care Products, Inc.
    Bingham Farms, MI 48205-3463
    Made In China
  • PRINCIPAL DISPLAY PANEL

    Antibacterial Hand Soap

  • PRINCIPAL DISPLAY PANEL

    Antibacterial Hand Soap

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE ANTIBACTERIAL HAND  
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9038
    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)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9038-6221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/11/2011
    Labeler - Personal Care Products, LLC (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co Ltd530766098manufacture
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