Label: KLEENEX ANTIMICROBIAL SKIN CLEANSER- benzalkonium chloride solution

  • 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 November 12, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For External Use Only.

    When using this product avoid contact with eyes; in case of contact, flush eyes with water.

    Stop use & ask a doctor if irritation or redness develops or persists.

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

  • Directions

    Wet hands and apply a palmful to hands. Scrub thoroughly for 15-20 seconds. Rinse and dry thoroughly.

  • Other Information

    Report serious side effects from this product to 1-877-561-6587

  • Inactive Ingredients

    Water/Eau/Aqua, Cocamidopropylamine Oxide, Polysilicone-20, Cetrimonium Chloride, Di-PPG-2 Myreth-10 Adipate, Benzyl Alcohol, Polymethacrylamidopropyltrimonium Chloride, Tetrasodium Iminodisuccinic Acid, Citric Acid, Aminomethyl Propanol

  • Questions?

    1-888-346-4652

  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199

  • PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

    Kleenex®
    BRAND

    Antimicrobial Foam
    Skin Cleanser

    Triclosan Free
    1 Liter (33.8 fl oz)

    20-14-736-0-00

    Principal Display Panel - 1 Liter Bottle Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX ANTIMICROBIAL SKIN CLEANSER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-440
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.013 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Cocamidopropylamine Oxide (UNII: M4SL82J7HK)  
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Di-PPG-2 Myreth-10 Adipate (UNII: 4IN301M0KJ)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-440-101 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:55118-440-121.2 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:55118-440-151.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/20/2013
    Labeler - Kimberly-Clark Corporation (006072136)
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