Label: TORK PREMIUM HAND SANITIZER FOAM ALCOHOL-FREE- benzalkonium chloride 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

    0.1% Benzalkonium Chloride

  • Purpose

    Antiseptic cleanser

  • Use

    • To decrease potentially harmful germs on skin.
  • 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

    • Place hands under the dispenser allow 0.4ml of foam into hands, rub thoroughly over the surface of both hands for at least 30 seconds, and then allow hands dry.
  • Inactive Ingredients

    • Water (Aqua), Dihydroxypropyl PEG-5 Linoleammonium Chloride, Glycereth- 2 Cocoate, Behentrimonium Chloride, Aloe Barbadensis Leaf Juice, Glycerin, Fragrance, Dihydroxyethyl Cocamine Oxide.
  • 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 Bag Carton

    TORK®
    Premium
    40 02 13

    Hand Sanitizer
    Foam
    Alcohol-Free
    with 0.1% Benzalkonium Chloride

    S21 System

    FR Déinfectant pour
    les mains

    Mousse
    Sans alcool
    avec 0.1% Benzalkonium
    Chloride

    ES Desinfectante de
    monos

    Espuma
    Sin alcohol
    con 0.1% Benzalkonium
    Chloride

    27 fl oz
    800ml

    SCA

    PRINCIPAL DISPLAY PANEL - 800 mL Carton
  • INGREDIENTS AND APPEARANCE
    TORK PREMIUM HAND SANITIZER FOAM ALCOHOL-FREE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49351-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dihydroxypropyl PEG-5 Linoleammonium Chloride (UNII: 0Y0NQR2GH1)  
    Glycereth-2 Cocoate (UNII: JWM00VS7HC)  
    Behentrimonium Chloride (UNII: X7GNG3S47T)  
    Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49351-016-011 in 1 BOX
    1800 mL in 1 BAG
    2NDC:49351-016-024 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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