COVIXYL-G by Salvacion USA, Inc. / Salvacion USA Inc.

COVIXYL-G by

Drug Labeling and Warnings

COVIXYL-G by is a Otc medication manufactured, distributed, or labeled by Salvacion USA, Inc., Salvacion USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COVIXYL-G- benzalkonium chloride 0.13% solution 
Salvacion USA, 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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Package display panel

Keep out of reach of children

Purpose - Antiseptic

Active ingredient

Directions

Do not use

Stop use and ask a doctor

Nasal Antiseptic soution, Benzalkonium Chloride 0.13%

Solution / drops and Benzalkonium Chloride 0.13%

Inactive ingredients

Questions ? Call

Warngins For extenal use only

Warning for external use only

COVIXYL-G 
benzalkonium chloride 0.13% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80857-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.0013 g  in 1 mL

Product Characteristics
Color	gray (color of solution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80857-100-01	1 in 1 CARTON	11/16/2020
1		20 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/16/2020	03/22/2023

Labeler - Salvacion USA, Inc. (028540090)

Registrant - Salvacion USA, Inc. (028540090)

Establishment
Name	Address	ID/FEI	Business Operations
Salvacion USA Inc.		028540090	manufacture(80857-100)

Revised: 3/2023

Document Id: f7ebe681-0976-ede6-e053-6294a90ac04b

34390-5

Set id: b3d70f48-ee6a-c9c0-e053-2995a90a7b60

Version: 5

Effective Time: 20230327