HAND SANITIZER (ALCOHOL) GEL [SWINTON AVENUE TRADING LTD, INC.]

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  • HAND SANITIZER (ALCOHOL) GEL [SWINTON AVENUE TRADING LTD, INC.]

HAND SANITIZER (ALCOHOL) GEL [SWINTON AVENUE TRADING LTD, INC.]
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NDC 62440-370-34, 62440-370-45, 62440-370-49
Set ID e32766f8-000c-4f04-b195-7cc13a4d00a8
Category HUMAN OTC DRUG LABEL
Packager Swinton Avenue Trading Ltd, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active Ingredient

    Ethyl alcohol 70%

  • purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommend 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 thoroghly 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, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

  • Questions?

    Call 1-866-795-8481

  • SPL UNCLASSIFIED SECTION

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

    Distributed by: Swinton Avenue Trading Ltd., Inc.

    6600 N. Military Trail, Boca Raton, FL 33496 USA

    Made in USA with US and Foreign components

    U.S. Pat. 9,161,982

  • principal display panel

    HIGHMARK

    ADVANCED

    Hand Sanitizer

    MOISTURIZING WITH VITAMIN E

    Kills 99.99% of germs

    8 FL OZ (236.6 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62440-370
    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 INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62440-370-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2014
    2NDC:62440-370-49443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2014
    3NDC:62440-370-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2014
    Labeler - Swinton Avenue Trading Ltd, Inc. (153531108)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(62440-370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(62440-370)
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