EClean Solution Advanced Antiseptic Hand Sanitizer Foam

EClean Solution Advanced Antiseptic Hand Sanitizer Foam by

Drug Labeling and Warnings

EClean Solution Advanced 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 SOLUTION ADVANCED ANTISEPTIC HAND SANITIZER FOAM- benzalkonium chloride aerosol, foam 
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 Solution Advanced Antiseptic Hand Sanitizer Foam

Drug facts

Active Ingredient

Benzalkonium chloride 0.1 %

Purpose

Antiseptic

Use

for hands washing to decrease bacteria on the skin

Warnings:

For external use only, hands only

When using this product

  • avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water
  • avoid contact with broken skin.

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persist for more than 72 hours.

Keep out of reach of children.

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

Directions

  • wet hands thoroughly with product and allow to dry without wiping 
  • for children under 6, use only under adult supervision.

Inactive ingedients

Purified water, cocoamidopropyl betaine, ethyl alcohol, fragance.

Questions or Comments?

210-837-6013

Package Labeling:

Bottle

ECLEAN SOLUTION ADVANCED ANTISEPTIC HAND SANITIZER FOAM 
benzalkonium chloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77538-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77538-011-01160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/202104/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/21/202104/21/2021
Labeler - Eksa Mills, S.A. de C.V. (951573231)

Revised: 4/2022