Label: BACTI-FREE TM ANTIBACTERIAL HAND- 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 April 2, 2012

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  • Active Ingredient

    Drug facts

    Active Ingredients  Triclosan 0.5%

  • Purpose

    Purpose Antibacterial

  • Keep Out Of Reach Of Children

    Keep out of reach of children.

  • Uses

    Uses: Decrease germs on the skin when used as a hand wash.

  • Warnings

    Warnings: For external use only. Do not use in or near the eyes. In case of eye contact flush with water. if accidently swallowed get medical help or contact a poison control center.

  • Directions for use

    Directions for use - Wet hands and apply soap. Rub briskly for 30 seconds paying particular attention to the interdigital areas. Rinse well

  • Inactive Ingredients

    Inactive Ingredients - Water, Coconut Diethanolamide, Vitamin E, Propylene Glycol, Methyl Paraben, Propyl Paraben.

  • Questions or Comments?

    Questions or Comments?

    1-800-473-9152

  • Bacti-Free tm Label

    Bacti-Free tm  Antibacterial Hand Soap

    If tape on carton has been cut or removed, then tampering may have occurred.

    128 oz. (3.78L)    Made in the u.S.A.

    Johnson Labs, Inc. Troy, AL 36081    334-566-9152    800-473-9152

    Lot # _____________________    Exp. ____________________

    Johnson Bacti-Free tm Label

  • INGREDIENTS AND APPEARANCE
    BACTI-FREE TM  ANTIBACTERIAL HAND
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59854-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.0189 L  in 3.78 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59854-300-013.78 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2000
    Labeler - Johnson Labs, Inc. (805806742)
    Registrant - Johnson Labs, Inc. (805806742)
    Establishment
    NameAddressID/FEIBusiness Operations
    Johnson Labs, Inc.805806742manufacture
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