Eclean Solution Gel Hand Sanitizer

Eclean Solution Gel Hand Sanitizer by

Drug Labeling and Warnings

Eclean Solution Gel 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 GEL HAND SANITIZER- alcohol gel 
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 Gel Hand Sanitizer

Drug Facts

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin. Recomended for repeated use.

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use

in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor

if irritation and redness develop and 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 - brisky rub hands together until dry - supervise children under 6 years in the use of the product.

Other information

Store at 69°F to 77°F (20° C to 25°C).
May discolor certain fabrics.

Inactive ingredients :

water, glycerin, thickener.

Package Labeling: 500ml

Package Labeling: 1L

Package Labeling: 1000L

ECLEAN SOLUTION GEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77538-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77538-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	06/01/2020
2	NDC: 77538-001-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	06/01/2020
3	NDC: 77538-001-03	1000000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020	06/01/2020

Labeler - Eksa Mills, S.A. de C.V. (951573231)

Revised: 4/2022

Document Id: dd05d9b3-9fa9-f215-e053-2995a90a06c3

34390-5

Set id: aa52ad92-7cbc-3efb-e053-2995a90ac5ab

Version: 5

Effective Time: 20220419