COVAGUARD- antimicrobial hand sanitizer spray with benzalkonium chloride spray

Covaguard by

Drug Labeling and Warnings

Covaguard by is a Otc medication manufactured, distributed, or labeled by Covalon Technologies Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13% w/w

PURPOSE

Antimicrobial Hand Sanitizer

WARNINGS

For external use only.

When using this product, avoid contact with eyes. If it comes in contact with eyes, rinse thoroughly with water.

Stop using and consult a healthcare practitioner if irritation develops.

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right away.

Keep out of reach of children

INSTRUCTIONS FOR USE

For up to 24h of increased protection against a wide range of microbes, fungi and viruses: Spray liberally on to hands and allow to dry.

STORAGE AND HANDLING

Store between 15C/59F to 30C/86F. (330.01 g)

INACTIVE INGREDIENT

Ethanol, Soy Phosphatidylcholine, Myristyl Alcohol, Didecyldimethylammonium Chloride, Sodium Bicarbonate, Disodium EDTA.

QUESTIONS

1-877-711-6055

DOSAGE & ADMINISTRATION

Spray on hands liberally. Rub thoroughly for at least 30 seconds. Allow to dry.

INDICATIONS & USAGE

Hand Sanitizer

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COVAGUARD 
antimicrobial hand sanitizer spray with benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75054-091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRUS SINENSIS LEAF (UNII: VF01D90MZI)	0.05 mL  in 100 mL
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)	0.2 g  in 100 mL
MYRISTYL ALCOHOL (UNII: V42034O9PU)	0.05 g  in 100 mL
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)	0.05 g  in 100 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	0.01 g  in 100 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO)	0.02 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M)	40 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75054-091-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/23/2020
2	NDC: 75054-091-02	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/23/2020
3	NDC: 75054-091-03	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/23/2020
4	NDC: 75054-091-04	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/23/2020

Labeler - Covalon Technologies Ltd. (206936101)

Registrant - Covalon Technologies Ltd. (206936101)

Establishment
Name	Address	ID/FEI	Business Operations
Covalon Technologies Ltd.		206936101	manufacture(75054-091)