Label: VIRX- instant hand sanitizer gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 23, 2010

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  • 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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