Label: HAND SANITIZER- ethyl alcohl liquid

  • NDC Code(s): 37012-439-34
  • Packager: Shopko Stores Operating Co., LLC
  • 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 14, 2022

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  • Active ingredient

    Ethyl alchol 70%

  • 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 skin irritation develops

  • 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, aloe barbadensis leaf juice, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance benzophenone-4, blue 1, yellow 5

  • Questions?

    Call 1-888-593-0593

  • SPL UNCLASSIFIED SECTION

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

    Made in the USA with US and foreign components
    Manufactured by Vi-Jon, Inc
    8515 Page Ave., St. Louis MO 63114
    for Shopko Stores Operating Co., LLC
    www.shopko.com

  • principl display panel

    ShopKo

    Anti-bacterial Hand Sanitizer With Aloe

    Advanced Formula

    Kills More Than 99.99% of Germs*

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-439
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL616 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-439-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/02/2013
    Labeler - Shopko Stores Operating Co., LLC (023252638)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37012-439)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37012-439)
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