Label: ANTIBACTERIAL HAND - triclosan soap 

  • NDC Code(s): 33992-0100-0
  • Packager: Greenbrier International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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  • Antibacterial Hand Soap
  • Active Ingredient

    Triclosan 0.15%

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  • Purpose

    Antibacterial

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  • Uses

    For hand washing to decrease bacteria on the skin.

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  • 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.

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  • Directions

    • pump into hands
    • lather vigorously for at least 15 seconds
    • rinse and dry thoroughly
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  • Other Information

    • store at room temperature
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  • 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.
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  • Antibacterial Hand Soap 16oz/500ml (33992-0100-0)
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-0100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM C14 OLEFIN SULFONATE  
    SODIUM LAURETH-3 SULFATE  
    COCO DIETHANOLAMIDE  
    SODIUM CHLORIDE  
    PEG-150 DISTEARATE  
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    EDETATE DISODIUM  
    .ALPHA.-TOCOPHEROL ACETATE  
    METHYLCHLOROISOTHIAZOLINONE  
    FD&C YELLOW NO. 5  
    METHYLISOTHIAZOLINONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-0100-0 500 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 12/05/2012
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Unichem Household Products Co., Ltd. 528196956 manufacture(33992-0100)
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