Label: ADVANCED- ethyl alcohol gel

  • NDC Code(s): 36800-370-16, 36800-370-34, 36800-370-45
  • Packager: TOPCO Assoc. 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 June 13, 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 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
  • Disclaimer

    • do not store above 105⁰F
    • 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?

    1-888-423-0139

  • Adverse event

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

    (c)TOPCO VIJA0223 QUESTIONS? 1-888-423-0139
    topcare@topco.com WWW.TOPCAREBRAND.COM

    **This product is not manufactured or distributed by GOJO Industries, Inc. distributor of Purell Refreshing Gel Advanced Hand Sanitizer.

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

    DSP-TN-21091   DSP-MO-20087

    DSP-MO-28   SDS-MO-20068

    QUALITY GUARANTEED

    This TopCare product is laboratory tested to guarantee its highest quality.

    Your total satisfaction is guaranteed.

    Scan here for more information or call 1-888-423-0139

  • Principal display panel

    TopCare

    everyday

    advanced

    hand

    sanitizer

    WITH VITAMIN E

    kills 99.9 of harmful germs*

    leaves hands feeling soft

    COMPARE TO PURELL

    ADVANCED HAND SANITIZER**

    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-370
    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 HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-370-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/27/2012
    2NDC:36800-370-1659 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/27/2012
    3NDC:36800-370-45946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/27/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/27/2012
    Labeler - TOPCO Assoc. LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(36800-370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-370)
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