Label: ANTIBACTERIAL- 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 October 26, 2011

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  • ACTIVE INGREDIENT



    Active Ingredient

    Triclosan 0.2%

  • PURPOSE



    Purpose  antibacterial

  • 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.

  • INDICATIONS & USAGE

    Uses

    for hand washing to decrease bacteria on the skin.

  • WARNINGS



    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.

  • DOSAGE & ADMINISTRATION



    Directions

    Pump into hands

    Lather vigorously for at least 15 seconds

    Rinse and dry thoroughly

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water (aqua), sodium laureth sulfate, sodium chloride, coamide DEA, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, yellow #5, red #40

  • PRINCIPAL DISPLAY PANEL

    label


    Kills 99% of germs

    Antibacterial soap

    Moisterizing hand soap

    15 fl oz (444 ml)

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.888 mL  in 444 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    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:29500-903-85444 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2011
    Labeler - Personal Care Products LLC (966155082)
    Registrant - Personal Care Products LLC (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products529047265manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo United Group Co Ltd544900137manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co Ltd528196956manufacture
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