Eclean Hand Sanitizer by Eksa Mills, S.A. de C.V. Eclean Hand Sanitizer

Eclean Hand Sanitizer by

Drug Labeling and Warnings

Eclean 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 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.

----------

Eclean Hand Sanitizer

Drug facts

Active Ingredient

Ethyl Alcoho 70%v/v

Purpose

Antimicrobial

Uses

• Hand sanitizer to decrease bacteria on the skin.
• Recommended for repeated use.

Warnings

• For external use only 
• Flammable 
• Keep away from fire or flame.

When using this product:

• Do not use in or near eyes.
• if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

• If irritation and redness persist for more than 72 hours.

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact a poison control center inmediately.

Directions

• Place enough product on your palm to thoroughly spread on both hands and rub into the skin until dry. 
• Children under six year of age should be supervised when using this product.

Other Information

• store at 1°C-30°C(34°F- 86°F)

Inactive ingedients:

Water,Carbomer,Triethanolamine, Glycerin and Aloe vera

Package Labeling:

ECLEAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77538-009
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77538-009-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2020	11/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/18/2020	11/18/2020

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

Revised: 4/2022

Document Id: dd3e18e6-481a-4216-e053-2a95a90a9dfd

34390-5

Set id: b476b136-ea4f-fbcb-e053-2995a90af6e5

Version: 2

Effective Time: 20220422