Label: 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 October 26, 2011

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  • ACTIVE INGREDIENT



    Active ingredient:

    Triclosan .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



    Use: 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 lauryl polyoxyethylene ether sulfate, sodium lauryl sulfate, dodecyl dimethyl betaine, coconut oil acid diethanolamine, citric acid, disodium edta, sodium chloride, DMDM hydantoin, fragrance, red 40, D and C red 33

  • PRINCIPAL DISPLAY PANEL

    label


    Personal Care antibacterial hand soap

    berry

    refill

    15 fl. oz (443 ml)

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.886 mL  in 443 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHER (UNII: 0F5N573A2Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BETAINE (UNII: 3SCV180C9W)  
    DIETHANOLAMINE (UNII: AZE05TDV2V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9077-7443 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/25/2011
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products529047265manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo United Group Co Ltd544900137manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    NingboUnichem Household Products Co Ltd528196956manufacture
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