Label: ANTIBACTERIAL HAND- triclosan soap

  • Category: HUMAN OTC DRUG LABEL

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 December 5, 2012

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  • Antibacterial Hand Soap


  • Active Ingredient

    Triclosan 0.15%

  • Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of 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
  • Other Information

    • store at room temperature
  • Inactive Ingredients

    water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, tocopheryl acetate, methylchloroisothiazolinone, fd c yellow no.5, methylisothiazolinone.
  • Antibacterial Hand Soap 16oz/500ml (33992-0100-0)

    HandSoap

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0100-0500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E12/05/2012
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co., Ltd.528196956manufacture(33992-0100)
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