Label: HAND KLEEN PREMIUM ANTIBACTERIAL HAND- triclosan soap 

  • Label RSS
  • NDC Code(s): 68604-023-01
  • Packager: Auto-Chlor System, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Triclosan 0.30% w/w


    Close
  • PURPOSE

    Antiseptic handwash


    Close
  • KEEP OUT OF REACH OF CHILDREN

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


    Close
  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on the skin.


    Close
  • WARNINGS

    For external use only.

    When using this product

    Do not get into eyes.

    If contact occurs, rinse eyes thoroughly with water.


    Close
  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands and forearms.
    • Apply 5 ml or palmful to hand and forearms.
    • Scrub thoroughly for at least 15 seconds.
    • Rinse completely and dry.

    Close
  • INACTIVE INGREDIENT


    Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Tetrasodium EDTA, Anionic/Nonionic Detergent Blend, Glycerin, Sodium Chloride, Lanolin, Sodium Xylenesulfonate, Citric Acid, Fragrance


    Close
  • PRINCIPAL DISPLAY PANEL

    productlabel

    image of product label

    Close
  • INGREDIENTS AND APPEARANCE
    HAND KLEEN PREMIUM  ANTIBACTERIAL HAND
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68604-023
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Triclosan (Triclosan) Triclosan 0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Sodium C14-16 Olefin Sulfonate  
    Sodium Laureth Sulfate  
    Lauryl Glucoside  
    Cocamidopropyl Betaine  
    Glycerin  
    Lanolin  
    Edetate Sodium  
    Glycol Distearate  
    Sodium Chloride  
    Coco Monoethanolamide  
    Laureth-12  
    Sodium Xylenesulfonate  
    Citric Acid Monohydrate  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68604-023-01 3780 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/22/2013
    Labeler - Auto-Chlor System, LLC (965194330)
    Establishment
    Name Address ID/FEI Business Operations
    Auto-Chlor Sytem, LLC 965194330 manufacture(68604-023)
    Close