Hand Sanitizer Alcohol 80%

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by IVM Especialidades Quimicas, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
IVM Especialidades Quimicas, S.A. de C.V.

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Hand Sanitizer Alcohol 80%

Active Ingredient(s)

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic.

Use

Hand Sanitizer to help reduce bacteria tt potentially can cause disease. For use when water and soap 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 15-30°C (59-86 °F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Glycerin, hydrogen peroxide, purified water.

Package Label - Principal Display Panel

1000 mL NDC: 80711-001-01

5000 ml NDC: 80711-001-02

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80711-001
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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80711-001-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2021	01/13/2025
2	NDC: 80711-001-02	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2021	01/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/03/2021	01/13/2025

Labeler - IVM Especialidades Quimicas, S.A. de C.V. (812761947)

Establishment
Name	Address	ID/FEI	Business Operations
IVM Especialidades Quimicas, S.A. de C.V.		812761947	manufacture(80711-001)

Revised: 1/2025

Document Id: 2b9e5996-dd45-1406-e063-6394a90afb9b

34390-5

Set id: c1737721-1df2-7611-e053-2a95a90a1a84

Version: 5

Effective Time: 20250113

 

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