Label: SMITH AND JOHNSON ANTIBACTERIAL- triclosan soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 19, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Triclosan 0.115%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    USES: For hand washing to decrease bacteria on the skin.

  • WARNINGS

    WARNING:

    For external use only.

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Keep out of reach of children.

    If swallowed, contact a poison control center immediately and consult a physician if necessary.


  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Wet hands
    • Apply palmful to hands
    • Scrub thoroughly
    • Rinse
  • WARNINGS AND PRECAUTIONS

    WARNING: AS WITH ANY SOAP, AVOID CONTACT WITH EYES, IN CASE OF CONTACT, FLUSH WITH WATER.

  • DESCRIPTION

    The Smith and  Johnson Liquid Soap is formulated to clean dirt and kill germs, an ideal high quality soap for the entire family.

  • INACTIVE INGREDIENT

    INGREDIENTS: Water, Sodium Polyoxyethylene Fatty Alcohol Sulfate, Coconut Oil Diethanolamide, Citric Acid, Kathon CG, Fragrance, Sodium Chloride, FD and C Yellow No.5, FD and C Red No.40.

  • SPL UNCLASSIFIED SECTION

    ITEM Number: 20063 /  4492

    MADE IN CHINA FOR

    ALLIED INTERNATIONAL CORP.

    Glen Burnie, MD 21060

    www.alliedint.com

  • PRINCIPAL DISPLAY PANEL

    Smith and Johnson

    Liquid Soap

    Antibacterial

    16.9 FL.OZ (500ml)

    LiquidSoap

  • INGREDIENTS AND APPEARANCE
    SMITH AND JOHNSON ANTIBACTERIAL 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52546-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.115 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-2 SULFATE (UNII: ZZQ59TY3KG)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIETHANOLAMINE (UNII: AZE05TDV2V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52546-110-00500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E05/19/2011
    Labeler - Allied International Corp (004001780)
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