FDA.reportPublic FDA data

Eclean Solution Hand Sanitizer Foam

Manufacturer
Eksa Mills, S.A. de C.V.
Effective date
2021-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:43:13

Label at a glance#

ProductEclean Solution Hand Sanitizer Foam
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Wet hands thoroughly with product and Wet your hands well with product and rub until dry for children under 6 years, use only under adult supervision.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.1 %

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

to decrease bacteria on the skin. •Rinse Free. •Recommended for repeated use.

Warnings:

WARNINGS SECTION

  • For external use only, hands only.

Do not use

OTC - DO NOT USE SECTION

  • in eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if redness and irritation develop and persist for more than 72 hours. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and Wet your hands well with product and rub until dry
  • for children under 6 years, use only under adult supervision.

Inactive ingedients

INACTIVE INGREDIENT SECTION

Purified water,  cocoamidopropyl betaine, ethyl alcohol, fragance.

Questions or Comments?

OTC - QUESTIONS SECTION

210-837-6013

Package Labeling:50ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner LabelBoxBox

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label2Outer Label2Inner Label2.jpgInner Label2.jpgBox2Box2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77538-01277538-012-01, 77538-012-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALCOHOL3K9958V90MIACT
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
dd3eac82-f77f-7b51-e053-2a95a90aaf17334e1118-4bc6-40e0-868e-da360b5b124a2022-04-22WarningsExact identifier
spl set id: 334e1118-4bc6-40e0-868e-da360b5b124a

Reported adverse events (FAERS/openFDA)#

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