Active Ingredient(s)

Alcohol 73% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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 this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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. If swallowed, get medical help or contact a Poison Control Center right away.

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. 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

glycerin, hydroxyethyl cellulose, triethanolamine, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

GVR HEC Gel Drug Facts

GRAND VALLEY REAGENTS HEC HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77750-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)	0.25 L in 100 L
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)	1 L in 100 L
GLYCERIN (UNII: PDC6A3C0OX)	1.25 L in 100 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 L in 100 L
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77750-002-55	208.2 L in 1 DRUM; Type 0: Not a Combination Product	05/22/2020
2	NDC:77750-002-27	1041 L in 1 CONTAINER; Type 0: Not a Combination Product	05/22/2020
3	NDC:77750-002-33	1249.2 L in 1 CONTAINER; Type 0: Not a Combination Product	05/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/22/2020

Labeler - Grand Valley Reagents, LLC (117497275)

Name	Address	ID/FEI	Business Operations
Establishment
Grand Valley Reagents, LLC		117497275	manufacture(77750-002)

Grand Valley Reagents HEC Hand Sanitizer Gel