Label: TRAILWAYS HAND SANITIZER- alcohol lotion

  • 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 22, 2010

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  • Active Ingredient

    Sanitizer.   Topical hand sanitizer containing Isopropyl Alcohol that is a fast acting, broad spectrum and persistent antiseptic containing preparation that significantly reduces the number of microorganisms on the skin.

    Use Information

    Requires no water or towels.  Apply small amount to hands and rub lightly until dry.
  • SAFE HANDLING WARNING


    Safety:     For External Use Only.

    Do not use in Eyes.  Avoid contact with eyes, should this occur rinse immediately with clean warm water.

    Discontinue use if redness or swelling develops.

    Flammable.  Do not use near fire or flame.

     
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  • INGREDIENTS AND APPEARANCE
    TRAILWAYS  HAND SANITIZER
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52305-144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) Alcohol250 mL  in 295 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ETHANOLAMINE (UNII: 5KV86114PT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52305-144-12295 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34106/01/2010
    Labeler - Freshorize, Ltd. (424168503)
    Registrant - Freshorize, Ltd. (424168503)
    Establishment
    NameAddressID/FEIBusiness Operations
    Freshorize, Ltd.424168503manufacture, repack, relabel
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