ALCOHOL ANTISEPTIC 80% HAND SANITIZER NON-STERILE SOLUTION- alcohol liquid

Alcohol Antiseptic 80% Hand Sanitizer Non-sterile Solution by

Drug Labeling and Warnings

Alcohol Antiseptic 80% Hand Sanitizer Non-sterile Solution by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Alcohol 80%v/v Antiseptic

PURPOSE

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if irritation or rash occurs. These may be serious signs of a serious condition.

WARNINGS

Warnings

For external use only. Flammable. Keep away from hear 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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL

Alcohol Antiseptic 80%

Topical Solution

Hand Sanitizer

Non-Sterile Solution

Merle Norman

177mL 6 FL. OZ.

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC 80% HAND SANITIZER NON-STERILE SOLUTION 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-190
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)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-190-01	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020
2	NDC: 57627-190-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/23/2020

Labeler - Merle Norman Cosmetics (008479388)

Registrant - Merle Norman Cosmetics (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics		008479388	manufacture(57627-190)