FDA.reportPublic FDA data

Ivresse Sanitizer Antibacterial Wet Wipes

Manufacturer
Ivresse Internacional, S.A. de C.V.
Effective date
2022-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:49:31

Label at a glance#

ProductIvresse Sanitizer Antibacterial Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

keep of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments:

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78740-00778740-007-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
TRISODIUM NITRILOTRIACETATEE3C8R2M0XDIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALLANTOIN344S277G0ZIACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
053f02f1-a155-5713-e063-6394a90a953fb3da4a31-6579-e36c-e053-2995a90ad7012023-09-13WarningsExact identifier
spl set id: b3da4a31-6579-e36c-e053-2995a90ad701

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.