WALTER 80% ALCOHOL LIQUID HAND SANITIZER- ethanol liquid

Walter 80% Alcohol Liquid Hand Sanitizer by

Drug Labeling and Warnings

Walter 80% Alcohol Liquid Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Walter Surface Technologies Inc., Walter Surface Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Alcohol 80% v/v

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Use

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

WARNINGS

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. If swallowed, get medical help or contact a Poison Control Center immediately.

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.

STORAGE AND HANDLING

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40“C (104°F)

INACTIVE INGREDIENT

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

WALTER
Walter Surface Technologies Inc.
5977 Trans Canada Highway, Pointe Claire
Quebec H9R 1C1 CANADA
QUESTIONS? USA 1-866-592-5837
walter.com

PRINCIPAL DISPLAY PANEL

WALTER

80% ALCOHOL

Antiseptic Topical Solution

LIQUID HAND SANITIZER

Non-Sterile Solution

55 U.S. GALLONS

208 L

MADE IN CANADA

INGREDIENTS AND APPEARANCE

WALTER 80% ALCOHOL LIQUID HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77621-002
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77621-002-01	208 L in 1 CONTAINER; Type 0: Not a Combination Product	05/13/2020
2	NDC: 77621-002-02	0.35 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/13/2020

Labeler - Walter Surface Technologies Inc. (202371878)

Establishment
Name	Address	ID/FEI	Business Operations
Walter Surface Technologies Inc.		202371878	manufacture(77621-002)