EWLEKA DISINFECTION GEL- 95%ethanol gel 
Keqin Cosmetics（shanghai）Co.,Ltd

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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Alcohol

Alcohol80% v/v Purpose: Antiseptic

Dosage

Dosage:

Take 3ml of this product and apply it to your hands.

for medical surgery hand disinfection：take 5ml- 10ml of this product

Administration: topical

Warnrings

1.This product is for external use, strictly forbidden to be taken orally.Please keep it out of reach of children.

2.This product contains alcohol, do not contact open flames.

3. This product contains alcohol, it should not be used if you are allergic to alhol.

4.This product is not suitable for disinfecting the surface of fat-soluble objects.

Inactive ingredient

water

glycerine

Usage

Take 3ml of this product and apply it to your hands, rub your hands for one minute until it is dry.

Medical Surgery hand disinfection: Wash your hands, lower 1/3of upperarm as specified, than take5ml-10ml of this product and evenly apply it to yourhands , rub your hands for 3 minutes until it is dry, put onsterile gloves at last.

Keep out of reach of children

This product is for external use ,strictly forbidden to be taken orally.

Purpose

It is used for hand disinfection.

Active ingredient

Active ingredient: ethanol

The labeling of Disinfection Gel

500ml label500ml NDC ：79239-001

EWLEKA DISINFECTION GEL 
95%ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79239-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79239-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
Labeler - Keqin Cosmetics（shanghai）Co.,Ltd (554537587)

Revised: 7/2020
Document Id: a81c53b3-d170-ecd2-e053-2995a90a90c4
Set id: a81c53b3-d16f-ecd2-e053-2995a90a90c4
Version: 1
Effective Time: 20200702
 
Keqin Cosmetics（shanghai）Co.,Ltd