Label: FOAMING HAND WASH- triclosan 0.46% 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 July 8, 2013

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  • Active ingredient

    Triclosan 0.46%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only - hands only

  • When using this product

    avoid contact with the eyes. If contact occurs, rinse eyes with water

  • Stop use and ask a doctor if

    irritation or redness develops

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control center right away.

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    water, sodium laureth sulfate, glcerin, cocamidopropyl betaine, ammonium xylenesulfonate, fragrance, disodium phosphate, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, red 4, yellow 5

  • questions

    Call 1-888-593-0593

  • adverse reactions

    ShopKo

    Satisfaction Guaranteed

    Made in the USA with US and foreign components

    Manufactured by Vi-Jon, Inc.,

    8515 Page Ave., St. Louis, MO 63114

    for Shopko Stores Operating Co., LLC

    www.shopko.com

  • Principal Display Panel

    ShopKo

    Antibacterial

    Hand Wash

    Refill

    Foaming

    For foaming soap dispensers only

    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND WASH 
    triclosan 0.46% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-962
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.46 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-962-96221 mL in 1 BOTTLE, PUMP
    2NDC:37012-962-45946 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/24/2012
    Labeler - Shopko Stores Operating Co., LLC (023252638)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(37012-962)
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