Label: HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 17, 2020

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  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antiseptic

  • Uses

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

    For external use only:hands

  • Flammable

    Keep away from heat and flame

  • 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
  • Stop use and ask a doctor

    • if irritation and redness develops
    • condition persists for more than 72 hours
  • Keep  out of reach of children

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

  • 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
  • Other information

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

    water, glycerin, tocopheryl acetate, retinyl palmitate, carbomer, fragrance, benzophenone-4, mannitol, cellulose, hydroxypropyl methylcellulose, ultamarines, blue 1, red 40, yellow 5

  • claims

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

  • adverse reactions section

    Distributed by: Vi-Jon 8515 Page Ave.  

    St. Louis, MO 63114

  • princpal display panel

    germ-x

    hand sanitizer

    coconut water

    KILLS 99.99% OF GERMS

    1.11 FL OZ (32 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-989
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL545 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-989-0632 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package10/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/08/2014
    Labeler - Vi-Jon (150931459)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(11344-989)
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