AG ALCOHOL ANTISEPTIC- alcohol gel

AG Alcohol Antiseptic by

Drug Labeling and Warnings

AG Alcohol Antiseptic by is a Otc medication manufactured, distributed, or labeled by Nivek Distribution, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient[s]

Alcohol 72% v/v

Purpose

Antiseptic

Use[s]

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.

f 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

Package Labeling

Package Labeling: 8ml

Package Labeling: 500ml

Package Labeling: 1000ml

Package Labeling: 3.785ml

INGREDIENTS AND APPEARANCE

AG ALCOHOL ANTISEPTIC 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77523-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.72 mL  in 1 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: 77523-000-00	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
2	NDC: 77523-000-02	8 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 77523-000-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 77523-000-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 77523-000-37	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/29/2020

Labeler - Nivek Distribution, LLC. (117511434)