Label: KLEENEX ANTIBACTERIAL SKIN CLEANSER- triclosan 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 29, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Triclosan, 0.50% w/w

  • Purpose

    Antiseptic

  • Use

    Antiseptic cleanser. For personal hand hygiene to help prevent the spead of certain bacteria.

  • Warnings

    For External Use Only.

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

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

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

  • Directions

    Wet hands and apply a palmful to hands. Scrub thoroughly for 15-20 seconds. Rinse and dry thoroughly. Use as part of your daily cleansing routine.

  • Other Information

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

  • Inactive Ingredients

    Water/Eau, Propylene Glycol, Sodium Citrate, Sodium Cumenesulfonate, Sodium Laureth Sulfate, Citric Acid, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Fragrance/Parfum, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

  • 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 - 1.2 Liter Container Label

    MARQUE
    Kleenex®
    BRAND

    Antibacterial Foam Skin Cleanser

    Triclosan Solution, House Std., 0.50%

    DIN:02339641
    For Personal / Domestic Use Only

    1.2 Liters (40.5 fl oz)

    20-14-700-0-00

    Principal Display Panel - 1.2 Liter Container Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX ANTIBACTERIAL SKIN CLEANSER 
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-565
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan5 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Sodium Cumenesulfonate (UNII: 5798KA13PG)  
    Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    PEG-7 Glyceryl Cocoate (UNII: VNX7251543)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-565-101 L in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:55118-565-121.2 L in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:55118-565-151.5 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corporation010765394MANUFACTURE(55118-565) , ANALYSIS(55118-565) , RELABEL(55118-565)
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