Label: SMITH AND JOHNSON ANTIBACTERIAL- triclosan liquid

  • 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 September 28, 2016

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  • Active ingredient

    Triclosan 0.115 percent

  • Uses

    For handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

    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.

  • Directions

    Wet hands. Apply palmful to hands. Scrub thoroughly . Rinse

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Citric Acid, Fragrance, DMDM Hydantoin, Tetrasodium EDTA

  • DESCRIPTION

    Designed in USA

    Made in China for

    Allied International Corp of VA

    PO Box 858 Ashburn, VA 20146 USA

    www.alliedint.com

  • Keep out of reach of children.

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

  • Purpose:

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    Smith and Johnson

    New

    Liquid Soap

    Antibacterial

    16 FL OZ (470 ML)

  • PRINCIPAL DISPLAY PANEL

    LiquidSoap

  • INGREDIENTS AND APPEARANCE
    SMITH AND JOHNSON ANTIBACTERIAL 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52546-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN115 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52546-100-16470 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/201009/28/2016
    2NDC:52546-100-401180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/201009/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/21/2010
    Labeler - Allied International Corp (004001780)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Longliqi Bioscience Co., Ltd.421547530manufacture(52546-100)
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