ALCOHOL WET WIPE gel HAND SANITIZER- hand sanitizer gel gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Daieme Cosmetic Co,.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Main active ingredient

70%(v/v) ethanol

SPL UNCLASSIFIED SECTION

• THIS ITEM HAS DISINFECTION FUNCTION, CONVENIENT USE TO KILL 99.9% OF GERMS.
• Effective for germs like: colibasillus. Candida albicans anc Staphylococcus aureus.
• Scope of application: hands cleaning and disifection.
• Main active ingredient: 70%(V/V)ethanol
• Ingredients: water, EDTA disodium, carbomer, triethanolamine, ethyalcohol.
• Usage: for hands disinfection, take out about 2ml of gel, rub it on the skin for 1 minute, it can be dry without washing. Repeated use make a slight sticky feeling, please wash with water.
• Notice: Flammable, please keep it away from fire.Please store it in an environment below 50℃.external used, don't take it by mouth, and don't contact with the eyes directly, once contacting with eyes,please wash eyes with plenty of clean water quickly. Please close it well after use to avoid volatilization.Take caution if you are allergic to alcohol.
• Period of validity: 2 years

Scope of application

Hands cleaning and disifection

Usage

for hands disinfection, take out about 2ml of gel, rub it on the skin for 1 minute, it can be dry without washing. Repeated use make a slight sticky feeling, please wash with water.

Notice

Flammable, please keep it away from fire.Please store it in an environment below 50℃.external used, don'ttake it by mouth, and don't contact with the eyes directly, once contacting with eyes,please wash eyes with plenty of clean water quickly. Please close it well after use to avoid volatilization.Take caution if you are allergic to alcohol.

Do not use

• Avoid contacting with eyes, and damaged skin

WHEN USING

Flammable, please keep it away from fire.Please store it in an environment below 50°c.external used, don'ttake it by mouth, and don't contact with the eyes directly, once contacting with eyes,please wash eyes with plenty of clean water quickly. Please close it well after use to avoid volatilization.Take caution if you are allergic to alcohol.

STOP USE

Take caution if you are allergic to alcohol.

KEEP OUT OF REACH OF CHILDREN

Keep our of reach of children. Avoid contacting with eyes, and damaged skin

Directions

Avoid contacting with eyes, and damaged skin

Other information

• Please store it in an environment below 50 ℃

ingredients

water, EDTA disodium, carbomer, triethanolamine, ethyl alcohol.

Package label

INGREDIENTS AND APPEARANCE

ALCOHOL WET WIPE 
alcohol wet wipe gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54237-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)	0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54237-031-01	1 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC: 54237-031-02	8 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 54237-031-03	10 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC: 54237-031-04	20 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC: 54237-031-05	25 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
6	NDC: 54237-031-06	48 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
7	NDC: 54237-031-07	50 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
8	NDC: 54237-031-08	80 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
9	NDC: 54237-031-09	100 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

HAND SANITIZER 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54237-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	0.28 mL  in 100 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	0.01 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)	0.28 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54237-030-01	2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 54237-030-02	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 54237-030-03	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
4	NDC: 54237-030-04	99 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
5	NDC: 54237-030-05	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
6	NDC: 54237-030-06	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
7	NDC: 54237-030-07	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
8	NDC: 54237-030-08	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
9	NDC: 54237-030-09	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
10	NDC: 54237-030-10	29.57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
11	NDC: 54237-030-11	118.28 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
12	NDC: 54237-030-12	236.56 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
13	NDC: 54237-030-13	473.12 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Guangzhou Daieme Cosmetic Co,.Ltd (542359812)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Daieme Cosmetic Co,.Ltd		542359812	manufacture(54237-030, 54237-031)