Label: ADVANCED HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 62440-439-34, 62440-439-45
  • Packager: Swinton Avenue Trading LTD.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 March 1, 2022

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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 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, 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 1-866-795-8481

  • SPL UNCLASSIFIED SECTION

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

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

    Distributed by: Switon Avenue Trading Ltd., Inc.
    6600 N. Military Trail, Boca Raton, FL 33496
    Highark is a trademark or registered trademark of OMX, Inc. Office Depot, Inc
    Made in USA with US and foreign components

    SDS-MO-15036 SDA-WI-2486 DSP-MO-28 DSP-MO-34

  • PRINCIPAL DISPLAY PANEL

    HIGHMARK

    ADVANCED HAND SANITIZER

    Compare to Purell Refreshing Aloe Advanced Hand Sanitizer*

    KILLS 99.99% OF GERMS**

    MOISTURIZING WITH VITAMIN E & ALOE

    32 FL OZ (946 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62440-439
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 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:62440-439-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/30/2014
    2NDC:62440-439-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2014
    Labeler - Swinton Avenue Trading LTD.Inc. (153531108)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(62440-439)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(62440-439)
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