VIRAXSHIELD- benzalkonium chloride liquid 
DGH Pharma, Inc.

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.

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Antibacterial Hand Soap

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 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 and consult 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.

Directions

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

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)

Revised: 10/2020
Document Id: b1077274-3168-656c-e053-2a95a90ae68c
Set id: a8ac2bbb-d85d-7987-e053-2995a90a6c93
Version: 2
Effective Time: 20201006
 
DGH Pharma, Inc.