FDA.reportPublic FDA data

Ipax Hand Sanitizer

Manufacturer
Ipax Atlantic LLC
Effective date
2020-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:16:17

Label at a glance#

ProductIpax Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonim Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer 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 out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 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

SPL UNCLASSIFIED SECTION

  • Close cap after use.
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Lautrimonium chloride, Citric acid, Caprylyl/capryl glucoside.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80240-000-012025-01-29C16284748780-1d6a99b39-94cf-a426-e053-dadaa90af4c2ae69daad-c431-f0a7-e053-2a95a90afb71
80240-000-012022-01-28C16284748780-1d6a99b39-94cf-a426-e053-dadaa90af4c2ae69daad-c431-f0a7-e053-2a95a90afb71

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80240-00080240-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
2ce1f7af-cb4f-efab-e063-6294a90a2f5fae69daad-c431-f0a7-e053-2a95a90afb712025-01-01WarningsExact identifier
spl set id: ae69daad-c431-f0a7-e053-2a95a90afb71

Reported adverse events (FAERS/openFDA)#

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