Label: KLEENEX MOISTURIZING INSTANT HAND SANITIZER- 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 September 24, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to decrease bacteria on the skin.

  • Warnings

    Flammable - Keep product away from fire or flame.

    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 thoroughly with product and allow to dry.

  • Other Information

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

    Water, Glycerin, Dimethicone, Carbomer, Petrolatum, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Panthenol, Hydroxypropylcellulose, Ceteth-10, Steareth-21, Poloxamer 335, Aloe Barbadensis Leaf

  • Questions?

    1-888-346-4652

  • SPL UNCLASSIFIED SECTION

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

    www.kcprofessional.com

  • PRINCIPAL DISPLAY PANEL - 1.5 mL Pouch Label

    MARQUE
    Kleenex*
    BRAND

    Moisturizing Instant
    Hand Sanitizer

    Contains Aloe & Vitamin E

    Single Use

    .05
    Fl Oz
    (1.5 mL)

    Principal Display Panel - 1.5 mL Pouch Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX MOISTURIZING INSTANT HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-480
    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)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Panthenol (UNII: WV9CM0O67Z)  
    Hydroxypropyl Cellulose (Type H) (UNII: RFW2ET671P)  
    Ceteth-10 (UNII: LF9X1PN3XJ)  
    Steareth-21 (UNII: 53J3F32P58)  
    Poloxamer 335 (UNII: G6DQL26D50)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-480-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    2NDC:55118-480-88236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:55118-480-2259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:55118-480-121200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    5NDC:55118-480-5515 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:55118-480-1130 mL 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 FINALpart333E03/01/2011
    Labeler - Kimberly-Clark Corporation (006072136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corporation010765394MANUFACTURE(55118-480) , ANALYSIS(55118-480) , RELABEL(55118-480)
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