HAND SANITIZER- alcohol gel 
IVM Especialidades Quimicas, 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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Hand Sanitizer Alcohol 80%

Active Ingredient(s)

Ethyl Alcohol 70% 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

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

Other information

Inactive ingredients


distilled water, glycerin, hydrogen peroxide, polyacrylic acid, triethanolamine.

Package Label - Principal Display Panel



1000 mL NDC: 80711-002-01

Hand Sanitizer_70_1000



5000 ml NDC:80711-002-02


Hand Sanitizer_70_5000

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80711-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80711-002-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
2NDC:80711-002-025000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/07/2021
Labeler - IVM Especialidades Quimicas, S.A. de C.V. (812761947)
Establishment
NameAddressID/FEIBusiness Operations
IVM Especialidades Quimicas, S.A. de C.V.812761947manufacture(80711-002)

Revised: 2/2023
Document Id: f4b092aa-b7fa-a114-e053-2a95a90a8d0d
Set id: c1c38e32-49ed-7cec-e053-2995a90a7c98
Version: 2
Effective Time: 20230214
 
IVM Especialidades Quimicas, S.A. de C.V.