Label: GLOBAL CLEAN INSTANT HAND SANITIZER- alcohol gel

  • 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 09/12

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient:

    Ethanol (60% v/v)

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  • Purpose:

    Anti-Microbial Hand Sanitizer

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  • Uses

    • Helps reduce bacteria that potentially can cause disease
    • Helps prevent cross contamination by hand contact
    • Recommended for repeated use
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  • Warning

    • For external use only
    • Flammable, keep away from fire, heat or flame

    • Keep out of reach of children.
    • Do not use near eyes
    • In case of eye contact flush with water for 15 minutes
    • If irritation persists stop use of product and get medical attention
    • In case of accidental ingestion seek medical attention or contact a poison control center immediately.
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  • Directions

    • Use no water or towels
    • Apply appropriate amount of product to palm of hand
    • Rub until hands are completely covered
    • Agitate lightly until dry
    • Let air dry for 15 seconds
    • Do not rinse or wipe with towel.
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  • Other Information

    • Store in a cool dry place below 104° F.
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  • Inactive Ingredients

    Water, Carbomer, Triethanolamine, PEG-75 Lanolin, Aloe Vera Gel, Fragrance.

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    GLOBAL CLEAN
    INSTANT HAND SANITIZER
    (GEL - TYPE)

    • Enhanced with Moisturizers
    • Kills disease causing germs within seconds
    • Effective against MRSA, VRE, E. coli (0157:H7)
          Staphylococcus, Streptococcus
         & other organisms
    • Assists with OSHA Bloodborne Pathogen Standard Compliance

    For Hospital And Professional Use Only
    See Drug Facts panel for additional information.

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    GLOBAL CLEAN INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53341-515
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    alcohol (alcohol) alcohol 600 mL  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    aloe  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53341-515-80 800 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/28/1998
    Labeler - Tranzonic Companies (007900020)
    Establishment
    Name Address ID/FEI Business Operations
    Canberra Corporation 068080621 MANUFACTURE(53341-515)
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