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 November 10, 2021

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

  • Active ingredient

    Ethyl alcohol 63%

  • Purpose

    Antiseptic

  • Use

    • 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 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 information

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

    water, glycerin, tocopheryl acetate, retinyl palmitate, acrylates/C10-30 alkyl acrylate crosspolymer, benzophenone-4, mannitol, cellulose, hydroxypropyl methylcellulose, fragrance, yellow 5, blue 1, red 4, ultramarines

  • SPL UNCLASSIFIED SECTION

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

    Questions or comments? 1-800-925-4733

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL60015
    100% satisfaction guaranteed
    walgreens.com

  • principal display panel

    Well at Walgreens

    NEW

    Hand Sanitizer Guava fruit

    scent

    • Kills 99.99% of germs

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0898
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL567 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)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0898-1659 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/04/2016
    Labeler - Walgreen (008965063)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0363-0898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0363-0898)