HAND SANITIZER (ETHYL ALCOHOL) GEL [SAM'S WEST INC.]

HAND SANITIZER (ETHYL ALCOHOL) GEL [SAM'S WEST INC.]
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NDC 68196-370-16, 68196-370-88
Set ID d1c49c3c-53ee-4914-aa02-cd84057254a2
Category HUMAN OTC DRUG LABEL
Packager Sam's West Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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

    Flammable, keep away from heat 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

    • 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
  • 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

  • SPL UNCLASSIFIED SECTION

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

    **Meets the FDQA healthcare personnel hand wash criteria.

    Distributed by Sam's West, Inc., Bentonville, AR 72716

    We would love to hear from you!  Call us at: 1-888-301-0332 8am-5pm Monday-Friday 

    Pat. 9161,982

    DSP-MO-28  DSP-MO-34

    370.000/370AB

  • principal display panel

    Member's Mark

    hand sanitizer

    Vitamin E

    Moisturizers

    Kills more than 99.99% of germs in 15 seconds*

    Formulated for healthcare** gentle enough for everyday use

    67.6 FL OZ (2 L)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-370
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-370-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2017
    2NDC:68196-370-882000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/17/2017
    Labeler - Sam's West Inc. (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(68196-370)

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