Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack

Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack by

Drug Labeling and Warnings

Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack by is a Otc medication manufactured, distributed, or labeled by Ivresse Internacional, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IVRESSE SANITIZER WET WIPES ANTIBACTERIAL TRAVEL PACK- benzalkonium chloride cloth 
Ivresse Internacional, 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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Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack

Drug Facts

Active Ingredient

Benzalkonium chloride 0.13% v/v

Purpose

Antiseptic

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.

Do not use

  • in children less than 2 months of age 
  • on open skin wounds

When using this product

keep out 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 to cover all surfaces. Rub hands together until dry.
  • supervise children under 6 years of age when use this product to avoid swallwoing

Other Information

  • store between 68-77°F (20-25°C)
  • do not expose to excessive heat 
  • TAMPER EVIDENT:Do not use if the sealable tab is open or torn.

Inactive ingredients

allantoin, benzyl alcohol, edetate sodium, fragrance, glycerin, phenoxyethanol, polyoxyl 40 hydrogenated castor oil, trisodium nitrilotriacetate, water.

Questions or comments:

Call +521 (55)5531 32 15 or E-mail: contacto@ivresse.com

Package Labeling:

1

IVRESSE SANITIZER WET WIPES ANTIBACTERIAL TRAVEL PACK 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78740-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78740-006-1010 in 1 POUCH09/02/202010/01/2022
15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/02/202010/01/2022
Labeler - Ivresse Internacional, S.A. de C.V. (814233193)

Revised: 9/2023
Document Id: 053ebe7e-7677-f26d-e063-6394a90a7830
Set id: ae5879ad-1beb-0ba5-e053-2995a90a1cbe
Version: 3
Effective Time: 20230913