Label: KLEENEX ANTISEPTIC HAND RUB WITH MOISTURIZERS- 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 November 3, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • 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 or persists.

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

  • Directions

    Use enough foam to cover your hands. Rub hands together briskly until 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

    Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Carbomer, Ceteth-10, Dimethicone, Glycerin, Hydroxypropylcellulose, Isopropanol, Panthenol, Petrolatum, Poloxamer 335, Steareth-21, 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

  • PRINCIPAL DISPLAY PANEL - 1 Liter Container Label

    Kleenex®
    BRAND

    Antiseptic Hand Rub
    with Moisturizers

    hydrates
    skin

    1 Liter (33.8 fl oz)

    20-14-695-0-00

    PRINCIPAL DISPLAY PANEL - 1 Liter Container Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX ANTISEPTIC HAND RUB WITH MOISTURIZERS 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Liquid Petroleum (UNII: 6ZAE7X688J)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Hydroxypropyl Cellulose (Type H) (UNII: RFW2ET671P)  
    Ceteth-10 (UNII: LF9X1PN3XJ)  
    Steareth-21 (UNII: 53J3F32P58)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Panthenol (UNII: WV9CM0O67Z)  
    Poloxamer 335 (UNII: G6DQL26D50)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-580-101 L in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E05/15/2012
    Labeler - Kimberly-Clark Corporation (006072136)
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