WIPES- alcohol wet wipe cloth HAND SANITIZER GEL- alcohol gel

Hand sanitizer gel by

Drug Labeling and Warnings

Hand sanitizer gel 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

Hand sanitizer gel:

2ml NDC: 54237-032-01

30ml NDC: 54237-032-02

60ml NDC: 54237-032-03

99ml NDC: 54237-032-04

100ml NDC: 54237-032-05

120ml NDC: 54237-032-06

300ml NDC: 54237-032-07

500ml NDC: 54237-032-08

1L NDC: 54237-032-09

1oz NDC: 54237-032-10

4oz NDC: 54237-032-11

8oz NDC: 54237-032-12

16oz NDC: 54237-032-13

Wipes:

1pcs NDC: 54237-033-01

8pcs NDC: 54237-033-02

10pcs NDC: 54237-033-03

20pcs NDC: 54237-033-04

25pcs NDC: 54237-033-05

48pcs NDC: 54237-033-06

50pcs NDC: 54237-033-07

80pcs NDC: 54237-033-08

100pcs NDC: 54237-033-09

INGREDIENTS AND APPEARANCE

WIPES 
alcohol wet wipe cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54237-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	34.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54237-033-01	3.49 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC: 54237-033-02	27.92 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 54237-033-03	34.9 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC: 54237-033-04	69.8 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC: 54237-033-05	87.25 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
6	NDC: 54237-033-06	167.52 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
7	NDC: 54237-033-07	174.5 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
8	NDC: 54237-033-08	279.2 g in 1 BAG; Type 0: Not a Combination Product	03/30/2020
9	NDC: 54237-033-09	349 g 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 GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54237-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54237-032-01	1.26 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 54237-032-02	18.9 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 54237-032-03	37.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 54237-032-04	62.37 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 54237-032-05	63 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 54237-032-06	75.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 54237-032-07	189 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 54237-032-08	315 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 54237-032-09	630 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 54237-032-10	18.63 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC: 54237-032-11	74.52 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC: 54237-032-12	149.03 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC: 54237-032-13	298.06 mL in 1 BOTTLE; 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(54237-032, 54237-033) , label(54237-032, 54237-033)