Label: FRESH UP ANTISEPTIC HAND - alcohol spray

  • NDC Code(s): 53859-001-00
  • Packager: G&G Medical Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active ingredient

    Ethyl Alcohol 70 percent

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  • Purpose

    Antiseptic

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  • Uses

    For hand washing to decrease bacteria on the skin.

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  • Warnings

    Flammable, keep away from fire or flame

    For external use only.

    Do not use

    • in the eyes
    • In case of eye contact, flush eyes with water.
    Stop use and ask a doctor if irritation and redness develop.

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  • Keep out of reach of children.

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


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  • Directions

    Spray enough product to thoroughly cover and wet hands. Rub hands together until dry. Children under 6 years of age should be supervised when using product.

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  • Other information

    Do not store above 40 degree Celsius (100 degree Fahrenheit).

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  • Inactive ingredients

    fragrance, glycerin, tocopheryl acetate, water

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  • Package labeling

    Kills Germs

    NDC 53859-001-00

    Fresh Up TM

    Antiseptic Hand Sanitizer Spray

    Over 150 Sprays!

    0.6 FL OZ (18 ml)

    Antiseptic Hand Sanitizer Spray

    Peel away for Drug Facts

    DISTRIBUTED BY:
    G AND G MEDICAL PRODUCTS, LLC
    P.O BOX 37, DEERFIELD STREET, NJ 08313
    UNITED STATES

    MADE IN CHINA
    www.gandgmed.com


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    Inside of back label


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  • INGREDIENTS AND APPEARANCE
    FRESH UP ANTISEPTIC HAND 
    alcohol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53859-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 70 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    .ALPHA.-TOCOPHEROL ACETATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53859-001-00 18 mL in 1 CARTRIDGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 11/07/2012
    Labeler - G&G Medical Products LLC (078645725)
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