GUARDEX HAND SANITIZER ANTISEPTIC GEL- isopropyl alcohol 75% gel

Guardex Hand Sanitizer Antiseptic Gel by

Drug Labeling and Warnings

Guardex Hand Sanitizer Antiseptic Gel by is a Otc medication manufactured, distributed, or labeled by Guardex Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Isopropyl Alcohol 75%

Purpose

Antiseptic

Uses

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

On 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.

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, hydrogen peroxide, Triethanolamine, carbomer, purified water USP

Guardex Hand Sanitizer gel

INGREDIENTS AND APPEARANCE

GUARDEX HAND SANITIZER ANTISEPTIC GEL 
isopropyl alcohol 75% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80307-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	2839 mL  in 3785 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE TRISTEARATE (UNII: HOM72YRP1F)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
(3-BROMOPROPYL)BENZENE (UNII: 6VX623QN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80307-001-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Guardex Labs, Inc. (117630183)

Registrant - Guardex Labs, Inc. (117630183)