HEROES ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION- alcohol solution

Heroes Alcohol Antiseptic 80% Topical Solution by

Drug Labeling and Warnings

Heroes Alcohol Antiseptic 80% Topical Solution by is a Otc medication manufactured, distributed, or labeled by Gold Eagle Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

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

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, purified water USP

SPL UNCLASSIFIED SECTION

Antiseptic Hand Rub Non-Sterile Solution

DO NOT AIR SHIP

©2020 Gold Eagle Co.

Gold Eagle Co.

4400 S. Kildare

Chicago, IL 60632

(800) 367-3245

goldeagle.com

MADE IN USA

21006 4.2020

Packaging

INGREDIENTS AND APPEARANCE

HEROES ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78007-111
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78007-111-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020
2	NDC: 78007-111-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020
3	NDC: 78007-111-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020
4	NDC: 78007-111-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2020

Labeler - Gold Eagle Co. (005123211)

Establishment
Name	Address	ID/FEI	Business Operations
Gold Eagle Co.		005123211	manufacture(78007-111)