Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 68016-370-16, 68016-370-34
  • Packager: Pharmacy Value Alliance 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 September 8, 2023

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  • Active Ingredient

    Ethyl alcohol 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 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

    • skin irritation or 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 105⁰ F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

  • Questions?

    Call 1-888-593-0593

  • Disclaimer

    *This product is not manufactured or distriubted by GOJO Industries, inc. distributer of Purell Advanced Hand Sanitizer.

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

  • Adverse reaction

    Distributed By:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    PV Independently Tested Satisfaction Guaranteed

    If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

    DSP-TN-21091

    DSP-MO-20087

    DSP-MO-28

    SDS-MO-20068

  • Principal Panel Display

    COMPARE TO PURELL® ADVANCED HAND SANITIZER

    Premier Value

    Advanced Hand Sanitizer

    Kills more than 99.99% of germs*

    PV Independently Tested Satisfaction Guaranteed

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-370-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2013
    2NDC:68016-370-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/31/2013
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(68016-370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(68016-370)
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