COVIGEL- ethyl alcohol liquid

CoviGel by

Drug Labeling and Warnings

CoviGel by is a Otc medication manufactured, distributed, or labeled by Flavorcraft Industries Inc, MaxPax LLC, Flavorcraft LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a gel hand sanitizer manufactured using only United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.

Active Ingredient(s)

Alcohol 80% v/v.

Purpose

Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP, glycerin, hydroxyethl cellulose, sodium hydroxide, fragrance.

CoviClean 1.25ml

1.25ml NDC, 74593-003-01

INGREDIENTS AND APPEARANCE

COVIGEL 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74593-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.03 mL  in 100 mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)	0.97 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	17.85 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74593-003-01	1.25 mL in 1 POUCH; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Flavorcraft Industries Inc (621632921)

Establishment
Name	Address	ID/FEI	Business Operations
MaxPax LLC		017038858	pack(74593-003)

Establishment
Name	Address	ID/FEI	Business Operations
Flavorcraft LLC		621632921	manufacture(74593-003)