Ivresse Sanitizer Antibacterial Wet Wipes

Ivresse Sanitizer Antibacterial Wet Wipes by

Drug Labeling and Warnings

Ivresse Sanitizer Antibacterial Wet Wipes 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 ANTIBACTERIAL WET WIPES- 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 Antibacterial Wet Wipes

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 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 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 68-77ºF (20-25ºC)
• do not expose to excesive 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, propylene glycol,
sodium hydroxide, trisodium nitrilotriacetate, water

Questions or comments:

Call: +52 1 (55)5531 32 15
or E-mail: contacto@ivresse.com

Package Labeling:

IVRESSE SANITIZER ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78740-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE SODIUM (UNII: MP1J8420LU)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78740-007-00	70 in 1 POUCH	10/01/2020	10/01/2020
1		2 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2020	10/01/2020

Labeler - Ivresse Internacional, S.A. de C.V. (814233193)

Establishment
Name	Address	ID/FEI	Business Operations
Ivresse Internacional, S.A. de C.V.		814233193	manufacture(78740-007)

Revised: 9/2023

Document Id: 053f02f1-a155-5713-e063-6394a90a953f

34390-5

Set id: b3da4a31-6579-e36c-e053-2995a90ad701

Version: 3

Effective Time: 20230913