Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 41250-697-06
  • Packager: Meijer Distribution, 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 April 22, 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 and flame.

  • When using this product

    • keep out of eyes.  Incase 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, carbomer, fragrance, hydroxypropyl methylcellulose, retinyl palmitate, tocopheryl acetate, mannitol, cellulose, ultramarines, yellow 6

  • Adverse reactions 

    Dist. By Meijer Distribution, Inc.

    Grand Rapids, MI 49544

    www.meijer.com

  • PRINCIPAL DISPLAY PANEL

    Meijer

    vanilla bean

    Hand Sanitizer

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-697
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL558 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-697-0659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/24/2014
    Labeler - Meijer Distribution, Inc. (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41250-697)
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