Label: ETHYL ALCOHOL- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 21, 2010

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  • PRINCIPAL DISPLAY PANEL

    Select medical products Instant Hand Sanitizer
  • INDICATIONS & USAGE

    DIRECTIONS:
    Place enough product in your palm to thoroughly cover your hands
    Rub hands together briskly until dry
    Children under 6 years of age should be supervised when using this product.
  • INACTIVE INGREDIENT

    Inactive ingredients Water (Aqua), Isopropyl Alcohol, Diisopropyl Sebacate, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Fragrance (Parfum)


  • WARNINGS

    Warnings
    Flammable. Keep away from fire or flame.For external use only
    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash appears and lasts
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
  • ACTIVE INGREDIENT

    Active Ingredient       Purpose
    Ethyl Alcohol 62%    Antimicrobial
  • PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    ETHYL ALCOHOL  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-652
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68345-652-17503 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33304/21/2010
    Labeler - PSS World Medical, Inc. (101822682)
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