Label: TORK PREMIUM- 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 March 29, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    0.5% Triclosan

  • Purpose

    Antiseptic Handwash

  • Use

    • For hand washing to decrease potentially harmful bacteria.
    • Repeat daily as needed.
  • Warnings

    • For external use only.
    • When using this product avoid contact with eyes, in case of eye contact, flush with water.
    • Stop use and ask a doctor, if irritation or redness persist.
    • Do not ingest.
    • Keep out of reach of children, if swallowed, do not induce vomiting, get medical attention.
  • Directions

    • Wet hands, place hands under the dispenser to allow 0.4ml of soap to squirt into hands, wash thoroughly for at least 30 seconds, rinse hands thoroughly with potable water after washing.
  • Inactive Ingredients

    • Water (Aqua), Propylene Glycol, Lactic Acid, Sodium Cumenesulfonate, Sodium Laureth Sulfate, Sodium Hydroxide, Cocamidopropyl Betaine, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone.
  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    SCA TISSUE NORTH AMERICA
    Neenah, Wisconsin 54956
    www.scatissue.com
    www.torkusa.com
    866-SCA-TORK (722-8675)

  • PRINCIPAL DISPLAY PANEL - 800 mL Carton

    TORK®
    Premium
    40 02 12

    Soap
    Foam
    Antibacterial
    with 0.5% Triclosan

    S21 System

    FR Savon
    Mousse
    Antibactérian
    avec 0.5% de Triclosan

    ES Jabón
    Espuma
    Antibacteriano
    con 0.5% de Triclosan

    27 fl oz
    800ml

    SCA

    PRINCIPAL DISPLAY PANEL - 800 mL Carton
  • INGREDIENTS AND APPEARANCE
    TORK PREMIUM 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49351-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49351-015-011 in 1 BOX
    1800 mL in 1 BAG
    2NDC:49351-015-024 in 1 CARTON
    21100 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/03/2010
    Labeler - SCA Tissue North America (005694349)
    Registrant - Rubbermaid Commercial Products LLC (049924368)
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