Walter Hand Sanitizer Gel

Walter 70% Alcohol Hand Sanitizer by

Drug Labeling and Warnings

Walter 70% Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Walter Surface Technologies Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WALTER 70% ALCOHOL HAND SANITIZER- ethanol gel 
Walter Surface Technologies Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Walter Hand Sanitizer Gel

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose
Antiseptic

Uses

to decrease bacteria on the skin.

Warnings
For external use only.

Flammable. Keep away from fire or flame.

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

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

Directions

• apply liberally to cover all surfaces of both hands
• rub hands together until dry
• supervise children under 6 years old
• not recommended for infants

Inactive ingredients

Water (aqua), Acrylates Copolymer, Propylene Glycol, Glycerin, Isopropyl myristate, Aminomethyl Propanol, dl-alpha Tocopherol acetate, Denatonium Benzoate

WALTER
Walter Surface Technologies Inc.
5977 Trans Canada Highway, Pointe Claire
Quebec H9R 1C1 CANADA
QUESTIONS?

USA 1-866-592-5837 | walter.com

WALTER

KILLS HARMFUL BACTERIA

Fragrance-free

70% ALCOHOL

HAND SANITIZER

WITH MOISTURE & VITAMIN E

GEL

16.9 FL.OZ. 500 mL

WALTER 70% ALCOHOL HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77621-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77621-004-13	0.5 L in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2020	05/31/2021
2	NDC: 77621-004-18	0.118 L in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2020	05/31/2021
3	NDC: 77621-004-02	0.35 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/17/2020	05/31/2021
4	NDC: 77621-004-09	0.946 L in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2020	05/31/2021
5	NDC: 77621-004-05	3.78 L in 1 JUG; Type 0: Not a Combination Product	11/17/2020	05/31/2021
6	NDC: 77621-004-20	20 L in 1 CONTAINER; Type 0: Not a Combination Product	11/17/2020	05/31/2021
7	NDC: 77621-004-11	208 L in 1 DRUM; Type 0: Not a Combination Product	11/17/2020	05/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/17/2020	05/31/2021

Labeler - Walter Surface Technologies Inc. (202371878)

Establishment
Name	Address	ID/FEI	Business Operations
Walter Surface Technologies, inc.		202371878	manufacture(77621-004)

Revised: 1/2022

Document Id: d66fc7bf-1bee-e5d5-e053-2a95a90a1143

34390-5

Set id: b452b576-8cc4-5e07-e053-2a95a90ac317

Version: 4

Effective Time: 20220119