Label: KLEENEX ANTIBACTERIAL 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

If you are a consumer or patient please visit this version.

View All Sections
  • 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 and 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. Lather vigorously for at least 15 seconds. Rinse and dry thoroughly.

  • Other Information

    • Report any serious side effects from this product to 1-877-561-6587
  • Inactive Ingredients

    Water, Cocamidopropylamine Oxide, Polysilicone-20, Cetrimonium Chloride, Di-PPG-2 Myreth-10 Adipate, Benzyl Alcohol, Polymethacrylamidopropyltrimonium Chloride, Fragrance, Tetrasodium Iminodisuccinate, 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 Carton

    Kleenex®
    BRAND

    Foam Antibacterial
    Skin Cleanser

    20-14-671-0-00

    1 Liter (33.8 fl oz)

    Principal Display Panel- 1 Liter Carton
  • INGREDIENTS AND APPEARANCE
    KLEENEX ANTIBACTERIAL SKIN CLEANSER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropylamine Oxide (UNII: M4SL82J7HK)  
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-560-101 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:55118-560-121.2 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 FINALpart333E03/01/2012
    Labeler - Kimberly-Clark Corporation (006072136)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!