HAND SANITIZER (ALCOHOL) LIQUID [VI-JON]

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HAND SANITIZER (ALCOHOL) LIQUID [VI-JON]
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NDC 11344-437-04, 11344-437-08, 11344-437-09, 11344-437-16, 11344-437-18, 11344-437-20, 11344-437-21, 11344-437-26, 11344-437-27, 11344-437-32, 11344-437-34, 11344-437-38, 11344-437-42, 11344-437-49, 11344-437-57, 11344-437-63, 11344-437-68, 11344-437-86
Set ID 41bb88f7-2d27-4720-8215-71864ed3a91c
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • claims

    germ-X

    Professional

    ORIGINAL

    HAND SANITIZER

  • ACTIVE INGREDIENTS

    Ethyl alcohol 63%

  • 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 fire 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 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 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 105°F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, benzophenone-4, fragrance, glycerin, tocopherol, water

  • claims

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

  • adverse reactions

    DISTRIBUTED BY: VI-JON, LLC

    8515 Page Ave

    ST. LOUIS, MO 63114

    vijonprofessional.com

  • principal display panel

    germ-X

    Professional

    ORIGINAL

    HAND SANITIZER

    kILLS 99.99% of Germs

    With Vitamin E

    128 FL OZ (1 GAL) 3.79 L

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-437
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-437-271150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    2NDC:11344-437-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    3NDC:11344-437-2044 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    4NDC:11344-437-1659 mL in 1 PACKAGE; Type 0: Not a Combination Product06/13/2016
    5NDC:11344-437-1873 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    6NDC:11344-437-2188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    7NDC:11344-437-26118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    8NDC:11344-437-63200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    9NDC:11344-437-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    10NDC:11344-437-38295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    11NDC:11344-437-32354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    12NDC:11344-437-49443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    13NDC:11344-437-04750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    14NDC:11344-437-42828 mL in 1 PACKAGE; Type 0: Not a Combination Product06/13/2016
    15NDC:11344-437-09887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    16NDC:11344-437-571656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    17NDC:11344-437-681972 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    18NDC:11344-437-0844 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/13/2016
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC150931459manufacture(11344-437)
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