Label: VIRAXSHIELD- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 6, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13% w/w. Purpose: Antibacterial

  • Purpose

    Antibacterial hand soap

  • Use

    To eliminate viruses and bacteria on the skin

  • Warnings

    For external use only.

  • WHEN USING

    When using this product keep out of eyes. In case of contact, flush eyes with water.



    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 assistance or contact a Poison Control Center immediately.

  • STOP USE

    Stop use and consult a doctor if irritation or redness develops - condition persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

  • Directions

    • Wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    Benzyl Alcohol, Citrus Sinensis (Orange) Fruit Oil, Coamide DIPA, Cocamidopropyl Betaine, Cocamidopropyl PG-Dimonium Chloride Phosphate, C12-C14 Alkyl Olefin Sulfonate, Dehydroacetic Acid, Disodium EDTA, Water

  • Package Label - Principal Display Panel

    118 mL Hand Soap

  • Additional label

    118 mL Impact Soap

  • INGREDIENTS AND APPEARANCE
    VIRAXSHIELD 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77238-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.25 g  in 100 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 30 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q) 3.5 g  in 100 mL
    SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71) 3.5 g  in 100 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.05 g  in 100 mL
    DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.375 g  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.375 g  in 100 mL
    ORANGE OIL (UNII: AKN3KSD11B) 0.1 g  in 100 mL
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) 0.75 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77238-211-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    2NDC:77238-211-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - DGH Pharma, Inc. (128884560)
    Registrant - DGH Pharma, Inc. (128884560)
    Establishment
    NameAddressID/FEIBusiness Operations
    DGH Pharma, Inc.128884560manufacture(77238-211)
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