Ewleka Disinfection Gel

Manufacturer: Keqin Cosmetics（shanghai）Co.,Ltd
Effective date: 2020-07-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:21:33

Label at a glance#

ProductEwleka Disinfection Gel

Active ingredientALCOHOL

Label structure9 sections

Label contents#

Full prescribing information#

Alcohol

OTC - ACTIVE INGREDIENT SECTION

Alcohol80% v/v Purpose: Antiseptic

Dosage

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

INACTIVE INGREDIENT SECTION

water

glycerine

Usage

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

It is used for hand disinfection.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: ethanol

The labeling of Disinfection Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml label500ml NDC ：79239-001

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79239-001-02	2022-01-28	C162847	48780-1	d6a99b39-de7d-a426-e053-dadaa90af4c2	a81c53b3-d16f-ecd2-e053-2995a90a90c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79239-001-02	Ewleka Disinfection Gel	500 mL in 1 BOTTLE	GEL	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79239-001	EWLEKA DISINFECTION GEL (95%ETHANOL) GEL [KEQIN COSMETICS（SHANGHAI）CO.,LTD]	1	Legacy NDC, 1 package rows	20200716_a81c53b3-d16f-ecd2-e053-2995a90a90c4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Ewleka Disinfection Gel
95%Ethanol
GLYCERIN
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79239-001	79239-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a81c53b3-d170-ecd2-e053-2995a90a90c4			a81c53b3-d16f-ecd2-e053-2995a90a90c4	2020-07-02	Warnings	Exact identifier spl id: a81c53b3-d170-ecd2-e053-2995a90a90c4 spl set id: a81c53b3-d16f-ecd2-e053-2995a90a90c4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.