Label: TORK FOAM ANTIBACTERIAL- benzalkonium chloride soap

  • NDC Code(s): 49351-104-01, 49351-104-02
  • Packager: Essity Professional Hygiene North America LLC
  • 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 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium chloride, 0.13%

  • Purpose

    Antiseptic

  • Uses

    • For hand washing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only

    When using this

    product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if

    irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • Pump a small amount of foam into palm of hand  
    • Rub thoroughly over all surfaces of both hands for 15 seconds
    • Rinse with potable water
  • Inactive ingredients

    Water/Eau/Aqua, Coco-glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric acid.

  • Questions or Comments?

    1-866-722-8675

  • PRINCIPAL DISPLAY PANEL

    TORK®

    Foam Soap

    Antibacterial

    NDC 49351-104-01

    Manufactured for Essity Professional Hygiene North America, LLC

    2929 Arch Street

    Philadelphia, PA 19104

    www.torkusa.com

    For Commercial use

    Made in Mexico

    Premium

    1 L

    (33.8 US fl. oz.)

    (35.2 oz. liq.)

    Tork Label2.jpg

    Tork 104-02 50mL

  • INGREDIENTS AND APPEARANCE
    TORK FOAM ANTIBACTERIAL 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49351-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49351-104-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2017
    2NDC:49351-104-0224 in 1 BOX03/15/2017
    250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/15/2017
    Labeler - Essity Professional Hygiene North America LLC (005694349)
    Registrant - CYAN Labs S.A. de C.V. (812754130)
    Establishment
    NameAddressID/FEIBusiness Operations
    CYAN Labs S.A. de C.V.812754130manufacture(49351-104) , label(49351-104) , pack(49351-104)
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