Label: BACTI-FREE TM HAND SANITIZER- alcohol 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 Ingredients

    Drug Facts

    Active Ingredients    Ethyl Alcohol 62%

  • Purpose

    Purpose Topical Antimicrobial

  • Keep Out Of Reach Of Children

    For children under 6, use only under adult supervision. Not recommended for infants. If accidentally swallowed get medical help or contact a poison control center immediately.

  • Uses

    Uses - For hand washing to decrease germs on the skin.

  • Warnings

    Warnings - For external use only. Do not use in or near the eyes. If accidentally swallowed get medical help or contact a poison control center immediately.

  • Directions for use

    Directions for use - Wet hands throughly with product and allow to dry without wiping. For children under 6, use only under adult supervision.

  • Inactive Ingredients

    Inactive Ingredients - Water, Triethanolamine 85%, Tween 20, Carbopol 1342

  • Stop use and ask a Doctor

    Stop use and ask a Doctor - If skin irritation develops.

  • Questions or Comments?

    Questions or Comments?

    1-800- 473-9152

  • Bacti-Free tm Label

    Bacti-Free! tm  Hand Sanitizer

    16 oz. (0.473L)

    Johnson Labs, Inc  Troy, AL 36081   334-566-9152   1-800-473-9152

    Lot # __________    Exp. ___________

    Johnson Bacti-Free tm Label

  • INGREDIENTS AND APPEARANCE
    BACTI-FREE TM  HAND SANITIZER
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59854-299
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.29326 L  in 0.473 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59854-299-010.473 L in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2008
    Labeler - Johnson Labs, Inc. (805806742)
    Registrant - Johnson Labs, Inc. (805806742)
    Establishment
    NameAddressID/FEIBusiness Operations
    Johnson Labs, Inc.805806742manufacture
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