ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION - HAND SANITIZER

ALCOHOL ANTISEPTIC 80 TOPICAL - HAND SANITIZER by

Drug Labeling and Warnings

ALCOHOL ANTISEPTIC 80 TOPICAL - HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES M&L. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL ANTISEPTIC 80 TOPICAL - HAND SANITIZER- alcohol solution 
LABORATOIRES M&L

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ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION - HAND SANITIZER

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 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 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

Questions?

Call toll free 1 888 623 2880

Package Labeling:

ALCOHOL ANTISEPTIC 80 TOPICAL - HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 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: 10345-500-01	190 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	08/24/2020	03/01/2023

Labeler - LABORATOIRES M&L (262533623)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES M&L		262533623	manufacture(10345-500)

Revised: 2/2024

Document Id: 120e63d4-e4cb-05f0-e063-6394a90adfcf

34390-5

Set id: 14161930-7db2-4791-91c7-23c78fea9c07

Version: 4

Effective Time: 20240223