Hand Sanitizer by Antisépticos de México, S.A. de C.V.

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER- isopropyl alcohol gel 
Antisépticos de México, S.A. de C.V.

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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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.

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

Water(aqua), Glycerin, Carbomer, Triethanolamine

Package Label - Principal Display Panel

250 ml NDC: 76554-002-01

Package Label - Principal display panel

500 mL NDC: 76554-002-02

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76554-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	27 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76554-002-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020	06/05/2020
2	NDC: 76554-002-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020	06/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020	06/05/2020

Labeler - Antisépticos de México, S.A. de C.V. (951576637)

Registrant - Antisépticos de México, S.A. de C.V. (951576637)

Establishment
Name	Address	ID/FEI	Business Operations
Antisépticos de México, S.A. de C.V.		951576637	manufacture(76554-002)

Revised: 6/2020

Document Id: a75d8f63-0e9a-a25e-e053-2995a90a8d40

34390-5

Set id: a71dad9c-49f2-4797-e053-2a95a90aad0d

Version: 2

Effective Time: 20200605