Eclean Antiseptic Hand Sanitizer Foam

Eclean Antiseptic Hand Sanitizer Foam by

Drug Labeling and Warnings

Eclean Antiseptic Hand Sanitizer Foam by is a Otc medication manufactured, distributed, or labeled by Eksa Mills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECLEAN ANTISEPTIC HAND SANITIZER FOAM- benzalkonium chloride solution, concentrate 
Eksa Mills, 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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Eclean Antiseptic Hand Sanitizer Foam

Drug facts

Active Ingredient

Benzalkonium chloride 1.65 %

Purpose

Antiseptic

Use

for hands washing to decrease bacteria on the skin

Warnings:

For external use only.

Do not use

in the eyes.

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

  • 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

Cocamidopropyl betaine, ethyl alcohol, fragance.

Questions or Comments?

210-837-6013

Package Labeling:

Bottle

ECLEAN ANTISEPTIC HAND SANITIZER FOAM 
benzalkonium chloride solution, concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77538-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE16.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77538-008-0160 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/18/202011/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/18/202011/18/2020
Labeler - Eksa Mills, S.A. de C.V. (951573231)

Revised: 4/2022
Document Id: dd3de25b-1955-01f0-e053-2a95a90af5b2
Set id: b4765382-58a1-d7e1-e053-2995a90abb95
Version: 2
Effective Time: 20220422