Label: HAND SANITIZER- alcohol gel 

  • Label RSS
  • 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 ingredients

    Active ingredient

    Ethyl alcohol 65%

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  • Purpose

    Purpose

    Antispetic

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  • Use

    Use

    • 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

    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 without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
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  • Inactive ingredients

    Inactive ingredients aloe barbadensis leaf juice, benzophenone-4, blue 1, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, red 33, tocopheryl acetate, water

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  • other information

    Other information:

    • Do not store abut 105°F.
    • May discolor sme fabrics
    • Harmful to wood finishes and plastics
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  • claims

    Effective at eliminating 99.99% of many common harmful germs and bacteria in as littlw as 15 seconds

    MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

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  • Adverse reactions section

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

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  • Principal Display Panel

    DG health

    Instant

    Hand

    Sanitizer

    with Lavender

    + Chamomile

    • Kills 99.99% of germs

    8 FL OZ (236 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-523
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 650 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    SULISOBENZONE  
    FD&C BLUE NO. 1  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    PROPYLENE GLYCOL  
    D&C RED NO. 33  
    .ALPHA.-TOCOPHEROL ACETATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-523-34 236 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 08/19/2010
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 088520668 manufacture(55910-523)
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