Label: ANTIBACTERIAL CITRUS FRESH- 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 April 4, 2011

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  • ACTIVE INGREDIENT

    Active ingredient
    Triclosan (0.115%

    Purpose
    Antibacterial
  • INDICATIONS & USAGE

    Use for handwashing to decrease bacteria on the skin
  • WARNINGS

    Warnings
    For external use only-hands only

    When using this product
    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION

    Directions •wet hands •apply palmful to hands •scrub thoroughly •rinse
  • INACTIVE INGREDIENT

    Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, acrylates copolymer, cocamidopropyl betaine, methyl gluceth-10, PPG-10 methyl glucose ether, fragrance, sodium chloride, cocamide MEA, sodium hydroxide, benzyl alcohol, butyrospermum parkii (shea butter), tetrasodium EDTA, mannitol, cellulose, mica, acrylates/ammonium methacrylate copolymer, triethyl citrate, citric acid, titanium dioxide, iron oxides, alumina, hydroxypropyl methylcellulose, yellow 5, red 33
  • SPL UNCLASSIFIED SECTION

    50% more than the 7.5 FL OZ size
    Made in the USA with US and foreign components
    This product is not manufactured or distributed by Colgate-Polmolive Company, distributor of Softsoap Kitchen Fresh Hands Antibacterial Hand Soap

  • ADVERSE REACTIONS

    Distributed by:
    Wal-Mart Stores Inc.
    Bentonville, AR 72716
    Satisfaction quaranteed - Or we'll replace it or give you your
    money back.  For questions or comments or to report an
    undesired reaction or side effect, please call 1-888-287-1915.
  • PRINCIPAL DISPLAY PANEL

    50% MORE
    equate
    compare
    to Softsoap
    Kitchen Fresh
    Hands
    Antibacterial
    Citrus Fresh
    Kitchen Hand Soap
    11.25 FL OZ (332 mL)
    PEEL OFF LABEL
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL CITRUS FRESH 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-954
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.115 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICA (UNII: V8A1AW0880)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-954-96.221 L in 1 BOTTLE, PUMP
    2NDC:49035-954-81.333 L in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/19/2010
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi Jon (150931459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon150931459manufacture
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