Label: INSTANT HAND SANITIZER FRESH ALOE - 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 12/12

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  • ACTIVE INGREDIENT

    Active ingredients
    Ethyl Alcohol 62% v/v
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  • PURPOSE

    Purpose
    Antimicrobial
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  • INDICATIONS & USAGE

    KILLS MORE THAN 99.99% OF COMMON GERMS
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  • WARNINGS

    WARNING:
    Flammable, Keep away from fire or flame.  FOR EXTERNAL USE ONLY. DO NOT USE IN THE EYES. Close
  • STOP USE

    DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP. IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
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  • DOSAGE & ADMINISTRATION

    DIRECTIONS:
    Rub into skin until dry.
    Other Information:
    Store below 110 F.
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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:Water, Aloe barbadenis, Leaf Juice, Glycerin,

    Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Blue NO.1

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  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER FRESH ALOE  
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53603-1003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Alcohol (Alcohol) Alcohol 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALOE  
    ALOE VERA LEAF  
    GLYCERIN  
    PROPYLENE GLYCOL  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    TROLAMINE  
    .ALPHA.-TOCOPHEROL ACETATE  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53603-1003-2 59.1 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/06/2012
    Labeler - BB17, LLC (828378294)
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