Label: KLEENEX FOAM HAND SANITIZER- benzalkonium chloride solution

  • NDC Code(s): 55118-701-10, 55118-701-11, 55118-701-12, 55118-701-18, view more
    55118-701-64, 55118-701-67, 55118-701-99
  • Packager: Kimberly-Clark
  • 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 July 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%w/w

  • Purpose

    Antiseptic cleanser

  • Use

    For personal hand hygiene to help prevent the spread of bacteria

  • Warnings

    For external use only. Do not ingest. Use with caution in children.

    Do not use if you are allergic to any ingredients.

    When using this product, avoid contact with eyes.

    If contact occurs, rinse with water.

    Stop use and ask a doctor if irritation develops.

    Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

  • Directions

    Apply small amount and rub thoroughly into hands for at least 30 seconds. Allow to dry. Not to be rinsed off with water (i.e. not to be used as a handwash). For occasional and personal domestic use. Supervise children when they use this product.

  • Other information

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

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice Powder, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Methylpropanediol, Panthenol, PEG-14M, Silica, Sodium Hydroxide, 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 - 532 mL Bottle Label

    Kleenex®

    Foam Hand Sanitizer

    alcohol
    free

    DIN: 02443252

    For Personal / Domestic Use Only

    18 fl oz (532 mL)

    PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX FOAM HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)  
    Polyethylene Oxide 600000 (UNII: 2126FD486L)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Aloe (UNII: V5VD430YW9)  
    Panthenol (UNII: WV9CM0O67Z)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-701-6424 in 1 CARTON09/01/2015
    1NDC:55118-701-1145 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:55118-701-99473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2015
    3NDC:55118-701-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product09/01/2015
    4NDC:55118-701-121200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product09/01/2015
    5NDC:55118-701-674 in 1 CARTON09/01/2015
    5NDC:55118-701-18532 mL in 1 BOTTLE, PUMP; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tri-Pac Inc.020844956MANUFACTURE(55118-701) , LABEL(55118-701) , PACK(55118-701)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cyan Labs812754130MANUFACTURE(55118-701) , LABEL(55118-701) , ANALYSIS(55118-701) , PACK(55118-701)
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