KLEENEX ANTIMICROBIAL FOAM SKIN CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]

KLEENEX ANTIMICROBIAL FOAM SKIN CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]
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NDC 55118-700-10, 55118-700-12, 55118-700-15, 55118-700-18, 55118-700-63, 55118-700-65, 55118-700-66
Set ID adf1024f-0470-4b04-b20e-6d3fa45fde50
Category HUMAN OTC DRUG LABEL
Packager Kimberly-Clark
Generic Name
Product Class
Product Number
Application Number PART333E
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1% w/w

  • Purpose

    Antiseptic cleanser

  • Use

    For personal hand hygiene to help prevent the spread of certain bacteria.

  • Warnings

    For External Use Only. Do not ingest

    Use with caution in children

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

    Discontinue use and consult a health care practitioner if irritation develops

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

    Do not use if you are allergic to any ingredients.

  • Directions

    Apply a small amount and lather hands in water for at least 30 seconds. Rinse well. Adults: Supervise children when using this product. Do not dilute product. For occasional use as needed.

  • Other Information

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

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice Powder, Citric Acid, Coco-Betaine, Glycerin, Panthenol, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Tocopheryl Acetate, Water.

  • Questions?

    1-888-346-4652

  • SPL UNCLASSIFIED SECTION

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

    Distributed in Canada by Kimberly-Clark Inc., Mississauga,
    Ontario L5B 3Y5.

  • PRINCIPAL DISPLAY PANEL - 50.7 fl oz Bottle Label

    Kleenex®
    BRAND

    Antimicrobial Foam
    Skin Cleanser

    Benzalkonium Chloride Solution, NF

    new active ingredient
    Benzalkonium
    Chloride

    DIN: 02443244
    For Personal / Domestic Use Only

    1.5 Liters (50.7 fl oz)

    Principal Display Panel - 50.7 fl oz Bottle Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX ANTIMICROBIAL FOAM SKIN CLEANSER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Coco-Betaine (UNII: 03DH2IZ3FY)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Aloe (UNII: V5VD430YW9)  
    Panthenol (UNII: WV9CM0O67Z)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-700-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2015
    2NDC:55118-700-636 in 1 CARTON09/01/2015
    2NDC:55118-700-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    3NDC:55118-700-652 in 1 CARTON09/01/2015
    3NDC:55118-700-121200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    4NDC:55118-700-662 in 1 CARTON09/01/2015
    4NDC:55118-700-151500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/01/2015
    Labeler - Kimberly-Clark (830997032)

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