HAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]

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HAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]
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NDC 11344-646-06
Set ID c711a48e-9275-4445-a371-981512396d88
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient

    Ethyl alcohol 62%

  • 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.  Incase 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 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 105⁰F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    water, glycerin, carbomer, fragrance, hydroxypropyl methylcellulose, retinyl palmitate, tocopheryl acetate, mannitol, cellulose, ultramarines, yellow 5, blue 1

  • SPL UNCLASSIFIED SECTION

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

    Distributed by: Vi-Jon, LLC  8515 Page Ave. St. Louis MO 63114

  • principal display panel

    Germ-X hand sanitizer sparkling pear

    KILLS 99.99% OF GERMS*

    1.11 FL OZ (32 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-646
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL558 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-646-0632 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/29/2014
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-646)
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