ALCOHOL ANTISEPTIC- alcohol solution

Alcohol Antiseptic by

Drug Labeling and Warnings

Alcohol Antiseptic by is a Otc medication manufactured, distributed, or labeled by J & S Chemical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient[s]

Alcohol 80% 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 2months 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 INGREDIENT

• Inactive Ingredients glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL

Principal Display Panel -

J&S Chemical ™

Alcohol Antiseptic 80%
Topical Solution

Hand Sanitizer

Non-sterile Solution

Manufactured in Compliance to FDA Guidelines

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76948-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	800 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Hydrogen Peroxide (UNII: BBX060AN9V)
Denatonium Benzoate (UNII: 4YK5Z54AT2)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76948-0005-1	19 L in 1 PAIL; Type 0: Not a Combination Product	03/27/2020
2	NDC: 76948-0005-2	208 L in 1 DRUM; Type 0: Not a Combination Product	03/27/2020
3	NDC: 76948-0005-3	1041 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

Labeler - J & S Chemical Corporation (074551862)

Establishment
Name	Address	ID/FEI	Business Operations
J & S Chemical Corporation		074551862	MANUFACTURE(76948-0005)