Eclean Solution Hand Sanitizer Spray

Eclean Solution Hand Sanitizer by

Drug Labeling and Warnings

Eclean Solution Hand Sanitizer 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 HAND SANITIZER- benzalkonium chloride spray 
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 Hand Sanitizer Spray

Drug facts

Active Ingredient

Benzalkonium chloride 0.1 %

Purpose

Antiseptic

Use

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

Warnings:

  • For external use only, hands only.

Do not use

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

Stop use and ask a doctor

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

Keep out of reach of children.

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

Directions

  • 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

Purified water,  cocoamidopropyl betaine, ethyl alcohol, fragance.

Questions or Comments?

210-837-6013

Package Labeling:60ml

Inner Label3Outer Label3Box3

ECLEAN SOLUTION HAND SANITIZER 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77538-013
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: 77538-013-025 in 1 BOX01/06/202101/06/2021
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/06/202101/06/2021
Labeler - Eksa Mills, S.A. de C.V. (951573231)
Establishment
NameAddressID/FEIBusiness Operations
Eksa Mills, S.A. de C.V.951573231manufacture(77538-013)

Revised: 4/2022
Document Id: dd7b4c07-6c79-0c45-e053-2995a90a67e4
Set id: fd1d2cf9-3aae-43a7-903e-b45eb0c23a40
Version: 2
Effective Time: 20220425