Label: ETHYL ALCOHOL gel

  • NDC Code(s): 49035-420-10, 49035-420-16
  • Packager: Wal-Mart Stores, Inc.
  • 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 December 6, 2022

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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 fire or 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 develop
    • 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 safety information

    • do not store above 105°F
    • may discolor some fabrics 
    • harmful to wood finishes and plastics
  • inactive ingredients

    water, glycerin, isopropyl myristate, fragrance, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, yellow 10, ext. violet 2

  • SPL UNCLASSIFIED SECTION

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

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

    143.001/143AB

  • principal display panel

    49035-420-10

    equate

    HAND SANITIZER

    Rosewater & Mint

    Kills 99.99% of Germs

    Contains Moisturizers

    1 FL OZ (29.5 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ETHYL ALCOHOL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-420-1029.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/2019
    2NDC:49035-420-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/03/2019
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygenic Products, Inc.421280161manufacture(49035-420)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(49035-420)
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