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

HAND SANITIZER (ETHYL ALCOHOL) GEL [SAM'S WEST INC]
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NDC 68196-951-16
Set ID 48960ca2-ddd6-40dc-bc21-25bb52f52ef2
Category HUMAN OTC DRUG LABEL
Packager Sam's West Inc
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • Use

    • 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

    skin irritation develops.

  • 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

    benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

  • SPL UNCLASSIFIED SECTION

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

    Distributed by SAM'S West, Inc.

    608 S.W. 8th Street

    Bentonville, AR 72716

    This product not packaged for resale

  • principal display panel

    Member's Mark Quality Guaranteed

    Hand Sanitizer

    Kills 99.99% of germs*

    Plus Moisturizers and Vitamin E

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-951
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL578 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    glycerin (UNII: PDC6A3C0OX)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-951-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/08/2014
    Labeler - Sam's West Inc (051957769)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(68196-951)

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