FDA.reportPublic FDA data

Eclean Antiseptic Hand Sanitizer Foam

Manufacturer
Eksa Mills, S.A. de C.V.
Effective date
2020-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:06:29

Label at a glance#

ProductEclean Antiseptic Hand Sanitizer Foam
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Apply the content of the sachet in 33.8 floz of water in your dispenser.  Seal and mix vigorouslyuntil incorporated.  Wet hands thoroughly with productand allow to dry without wiping.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 1.65 %

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for hands washing to decrease bacteria on the skin

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation and redness develop.
  • Condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply the content of the sachet in 33.8 floz of water in your dispenser. 
  • Seal and mix vigorouslyuntil incorporated. 
  • Wet hands thoroughly with productand allow to dry without wiping.

Inactive ingedients

INACTIVE INGREDIENT SECTION

Cocamidopropyl betaine, ethyl alcohol, fragance.

Questions or Comments?

OTC - QUESTIONS SECTION

210-837-6013

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 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77538-00877538-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
dd3de25b-1955-01f0-e053-2a95a90af5b2b4765382-58a1-d7e1-e053-2995a90abb952022-04-22WarningsExact identifier
spl set id: b4765382-58a1-d7e1-e053-2995a90abb95

Reported adverse events (FAERS/openFDA)#

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