Label: KLEENEX MOISTURIZING HAND SANITIZER, HYDRATES SKIN- alcohol 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 October 1, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Medicinal Ingredient

    Ethyl Alcohol, 62% v/v

  • Purpose

    Antiseptic

  • Use

    Antiseptic cleanser. Kills harmful bacteria or germs.

  • Warnings

    FLAMMABLE. Keep away from open flame and sources of heat.

    For External Use Only.

  • WHEN USING

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

  • STOP USE

    Stop use & ask a health care practitioner if irritation or redness develops or persists.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Use enough foam to cover your hands. Rub hands together briskly until dry. Use as part of your daily cleansing routine.

  • Other Information

    Report serious side effects from this product to 1-877-561-6587. Do not store above 110°F (40°C).

  • Non-Medicinal Ingredients

    Water/Eau, Betaine, Fragrance/Parfum, Meadowfoamamidopropyl Betaine, PEG-7 Glyceryl Cocoate, PEG-10 Dimethicone.

  • 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 - 1 Liter Container Label

    MARQUE
    Kleenex®
    BRAND

    Moisturizing Foam
    Hand Sanitizer

    hydrates
    skin

    NPN: 80015523

    For Personal / Domestic Use Only

    1 Liter (33.8 fl oz)

    20-14-708-0-00

    Principal Display Panel - 1 Liter Container Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX MOISTURIZING HAND SANITIZER, HYDRATES SKIN 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-545
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Betaine (UNII: 3SCV180C9W)  
    Peg-7 Glyceryl Cocoate (UNII: VNX7251543)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-545-88236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:55118-545-99473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:55118-545-1145 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:55118-545-101000 mL in 1 BAG; Type 0: Not a Combination Product
    5NDC:55118-545-121200 mL in 1 BAG; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corporation010765394MANUFACTURE(55118-545) , ANALYSIS(55118-545) , RELABEL(55118-545)
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