ACTIVE INGREDIENT(S)

Alcohol 80% v/v

PURPOSE

Antiseptic

Health care personnel hand rub to help reduce bacteria that potentially causes disease.

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

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

Stop using and ask 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.

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

glycerin, hydrogen peroxide, purified water USP

Call 1-855-274-4122

AUROHEALTH
NDC 58602-004-38
Alcohol Aniseptic 80%
Topical Solution
Antiseptic Hand Rub
Non-sterile Solution
128 OZ (3785 mL)

ALCOHOL ANTISEPTIC 80%
alcohol antiseptic 80% solution

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58602-004-38	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333A	06/25/2020

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurolife Pharma LLC		080970299	ANALYSIS(58602-004) , RELABEL(58602-004) , REPACK(58602-004) , LABEL(58602-004) , MANUFACTURE(58602-004) , PACK(58602-004)