Eclean Solution Hand Sanitizer Foam

Eclean Solution Hand Sanitizer Foam by

Drug Labeling and Warnings

Eclean Solution 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 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 Hand Sanitizer Foam

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:50ml

Outer LabelInner LabelBox

Package Labeling:

Outer Label2Inner Label2.jpgBox2

ECLEAN SOLUTION HAND SANITIZER FOAM 
benzalkonium chloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77538-012
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: 77538-012-015 in 1 BOX01/06/202101/06/2021
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 77538-012-024 in 1 BOX01/06/202101/06/2021
2250 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(77538-012)

Revised: 4/2022
Document Id: dd3eac82-f77f-7b51-e053-2a95a90aaf17
Set id: 334e1118-4bc6-40e0-868e-da360b5b124a
Version: 2
Effective Time: 20220422