Label: MEDI-PAK PERFORMANCE INSTANT HAND SANITIZER WITH ALOE - alcohol gel 

  • Label RSS
  • NDC Code(s): 68599-5309-0, 68599-5309-1, 68599-5309-2, 68599-5309-3
  • Packager: McKesson Medical-Surgical Inc.
  • 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 08/11

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  • ACTIVE INGREDIENT

    Active Ingredients

    Ethanol 64.5% (w/w)

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  • PURPOSE

    Purpose

    Hand Sanitizer

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  • INDICATIONS & USAGE

    Uses

    An antiseptic hand sanitizer for topical application

    Prevents infection and cross contamination

    Reduces transient microorganisms on intact skin

    Keep hands from drying out due to repeated uses

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  • WARNINGS

    Warnings

    For External Use Only

    Flammable, keep away from fire or flame

    When using this product

    Avoid contact with eyes

    In case of eye contact, flush with water for 15 minutes

    Discontinue use and see a doctor if irritation occurs

    Avoid contact with broken skin.

    Keep out of reach of children.

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

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  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands thoroughly with product.

    Allow to dry without wiping.

    Use no water or towels.

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  • SAFE HANDLING WARNING

    Other Information

    This product has not been tested on animals

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine, Glycerin, Fragrance, EDTA, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice, Yellow 5, Blue 1

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  • PRINCIPAL DISPLAY PANEL

    McKESSON

    Medi-Pak

    Performance

    Instant Hand

    Sanitizer

    with Aloe

    A no-rinse, moisturizing

    hand gel with Vitamin E,

    to decrease bacteria

    on the skin

    8 oz. (236 ml)

    container label

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  • INGREDIENTS AND APPEARANCE
    MEDI-PAK PERFORMANCE INSTANT HAND SANITIZER WITH ALOE 
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68599-5309
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 64.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)  
    EDETOL  
    GLYCERIN  
    EDETIC ACID  
    TOCOPHEROL  
    ALOE VERA LEAF  
    FD&C YELLOW NO. 5  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-5309-0 48 in 1 CASE
    1 74 mL in 1 BOTTLE, PLASTIC
    2 NDC:68599-5309-1 24 in 1 CASE
    2 118 mL in 1 BOTTLE, PLASTIC
    3 NDC:68599-5309-2 24 in 1 CASE
    3 236 mL in 1 BOTTLE, PLASTIC
    4 NDC:68599-5309-3 12 in 1 CASE
    4 443 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2003
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    Name Address ID/FEI Business Operations
    Central Solutions Inc 007118524 manufacture
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