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

HAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]
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NDC 11344-053-06, 11344-053-16, 11344-053-21, 11344-053-32, 11344-053-34, 11344-053-38, 11344-053-42
Set ID aea9f9ca-bcda-4e4e-830d-645e0e2c919c
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antiseptic

  • Uses

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

    aloe barbadensis gel, carbomer, FD&C blue no.1, FD&C  yellow no.5, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, tocopheryl acetate, water

  • Questions

    1-866 MY GERMX - 1-866-694-3769

  • SPL UNCLASSIFIED SECTION

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

    www.germx.com

  • principal display panel

    germ-X

    HAND SANITIZER

    KILLS 99.99% OF GERMS

    MOISTURIZING WITH ALOE

    3 fl oz (88 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL545 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    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:11344-053-1659 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/05/2009
    2NDC:11344-053-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2009
    3NDC:11344-053-42828 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2009
    4NDC:11344-053-2189 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/05/2009
    5NDC:11344-053-38295 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2009
    6NDC:11344-053-32355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2009
    7NDC:11344-053-06887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/05/2009
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-053)

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