Label: BEN E. KEITH ANTIBACTERIAL HAND CLEANER- triclosan liquid

  • 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 June 18, 2010

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  • ACTIVE INGREDIENT

    Triclosan 0.55 %

  • WARNINGS

    For external use only.  Do not use in eyes.

    In rare instances of irritation or redness, discontinue use if irritation or redness develop.  If condition persists for more than 72 hours consult a physician.  If swallowed, contact a physician or poison control center.  Keep out of reach of children.

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on skin.

  • WHEN USING

    Apply a small amount, covering hands with product for 30 seconds.  Add water, lather and rinse.

  • INACTIVE INGREDIENT

    Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, BHT, Styrene/Acrylates Copolymer, Glycerin, DMDM Hydantoin, Tetrasodium EDTA, Fragrance, Citric Acid.

  • PRINCIPAL DISPLAY PANEL

    Ben E. Keith 1200 mL bottle label

    Ben E. Keith 1200 mL bottle label

  • INGREDIENTS AND APPEARANCE
    BEN E. KEITH  ANTIBACTERIAL HAND CLEANER
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50980-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50980-078-261200 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/18/2010
    Labeler - Ben E. Keith Foods (007929748)
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