Label: 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 11/12

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

  • Active ingredient

    Active ingredient

    Ethyl alcohol 70%

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  • Purpose

    Purpose

    Antiseptic

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  • Uses

    Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
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  • Warnings

    Warnings

    For external use only-hands

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  • Flammable

    Flammable. Keep away from heat and flame.

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  • When using this product

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest
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  • Stop use and ask a doctor

    Stop use and ask a doctor if skin irritation develops

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  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Directions

    • wet hands thoroughly with product and allow to dry witout wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
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  • Other information

    Other information

    • do not store above 105⁰ F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
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  • Inactive ingredients

    Inactive ingredientswater, aloe barbadensis leaf juice,glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, blue 1, yellow 5

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  • Questions

    Questions? 1-888-593-0593

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  • claim

    Effective at eliminating more than 99.99% of many comon harmful germs and bacterial in as little as 15 seconds

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  • Disclaimer

    This product is not manufactured or distributed by GOJO Industries, Inc. distributor of Purell Refreshing Hand Sanitizer

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  • Adverse Reaction

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CN 4581591

    www.myleader.com

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  • Principal display panel

    NDC 37205-734-34

    LEADER

    Compare to Purell

    More

    Effective

    Formula

    Advanced

    Hand

    Sanitizer

    with Aloe

    Kills more than 99.99% of germs

    8 FL OZ (236 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-734
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 700 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALOE VERA LEAF  
    GLYCERYL CAPRYLATE/CAPRATE  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    .ALPHA.-TOCOPHEROL ACETATE  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    SULISOBENZONE  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-734-34 236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/09/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 088520668 manufacture(37205-734)
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