GUARDEX HAND SANITIZER ANTISEPTIC SOLUTION- isopropyl alcohol 75% liquid

Guardex Hand Sanitizer Antiseptic Solution by

Drug Labeling and Warnings

Guardex Hand Sanitizer Antiseptic Solution 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 Antiseptic Topical Solution

INGREDIENTS AND APPEARANCE

GUARDEX HAND SANITIZER ANTISEPTIC SOLUTION 
isopropyl alcohol 75% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80307-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	187.5 mL  in 250 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: 80307-002-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC: 80307-002-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC: 80307-002-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
4	NDC: 80307-002-33	1000 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)