VIRX (INSTANT HAND SANITIZER) GEL [FILO AMERICA]

VIRX (INSTANT HAND SANITIZER) GEL [FILO AMERICA]
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NDC 50438-807-15, 50438-807-16
Set ID 57ff1160-b266-4a8e-9189-893482b076c4
Category HUMAN OTC DRUG LABEL
Packager Filo America
Generic Name
Product Class
Product Number
Application Number PART333
  • ACTIVE INGREDIENT

    Active Ingredient...........................................................Purpose
    Ethyl Alcohol 62%...........................................................................Antiseptic
  • PURPOSE

    Use to decrease bacteria on the skin.
  • WARNINGS

    Warnings
    For external use only * Flammable * Keep away from fire or flame.
  • WHEN USING

    When using this product avoid contact with mouth, ears, and eyes.  In case of contact, flush eyes with water.
  • STOP USE

    Stop use and ask a doctor if redness or irritation develops and lasts more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
  • WHEN USING

    Directions
    Pump into palms and thoroughly rub into skin until dry.
  • WARNINGS AND PRECAUTIONS

    Other Information * store at 20 degrees Celcius (68 degrees to 77 degrees Farenheit) * may discolor fabrics.
  • INACTIVE INGREDIENT

    Deionized water, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, aminomethyl propanol, carbomer, fragrance and yellow 5.
  • PRINCIPAL DISPLAY PANEL

    MM1
    Image of bottle

    MM2
    Image of bottle

  • INGREDIENTS AND APPEARANCE
    VIRX 
    instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-807
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol496 mL  in 800 mL
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer 934 (UNII: Z135WT9208)  
    Product Characteristics
    Coloryellow (yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-807-15300 mL in 1 BOTTLE, PUMP
    2NDC:50438-807-16500 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33302/11/2010
    Labeler - Filo America (943873703)
    Registrant - Filo America (943873703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongyang Changdi Daily Sanitary Co., Ltd528198683manufacture

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