Label: FRESHORIZE 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 November 20, 2010

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

  • Active Ingredients

    62.5% Ethyl Alcohol.


    Use Information

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


    Safety:
    For External Use Only.Use on Hands only.

    Flammable.  Keep away from  fire or flame.

    Avoid contact with  Eyes, should this occur  rinse immediately with clean warm water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.



     
  • Display of package label.

    Picture of Package Label

    Image of Package Display



  • Keep out of reach of children

    Keep out of reach of children


  • Purpose

    Kills 99.9% Bacteria


  • DOSAGE & ADMINISTRATION

    Requires no water or towels.

    Apply small amount to hands and rub lightly until dry.

  • INACTIVE INGREDIENT

    Alcohol denat, Aqua, acrylates/C10-30 alkyl, acrylate cross polymer, triethanolamine (TEA), parfum

  • INGREDIENTS AND APPEARANCE
    FRESHORIZE  HAND SANITIZER
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52305-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) Alcohol185 mL  in 295 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ETHANOLAMINE (UNII: 5KV86114PT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52305-200-20295 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2010
    Labeler - Freshorize, Ltd. (424168503)
    Registrant - Freshorize, Ltd. (424168503)
    Establishment
    NameAddressID/FEIBusiness Operations
    Freshorize, Ltd.424168503manufacture