ALCOHOL HAND SANITIZER 80%- ethyl alcohol solution
Global Cosmetics (China) Company Limited

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 HAND SANITIZER 80%

Drug Facts

Active Ingredients

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Use[s]:

Hand Sanitizer to help reduce bacteria on skin

Warnings:

For external use only.

Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Place enough product on hands to cover all surfaces. Rub hands together until dry
• Supervise children under 6 years of age when using this product to avoid swallowing

Other information:

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)
• May discolour fabrics

Inactive Ingredients:

Denatonium Benzoate, Glycerin, Hydrogen Peroxide, Water(Aqua)

Questions or comments?

Emergency Contact Chemtel North America: 1-800-255-3924

Reference to WHO recommended formulation

Kills 99.9% of Germs

HAND RUB ANTISEPTIC SPRAY

Distributor: TV DIRECT LLC, 385 FIFTH AVENUE, SUITE 809, NEW YORK, NY 10016, USA

Tel: 212.268.2121

Made in China

Packaging

Sntizr13

ALCOHOL HAND SANITIZER 80%
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71650-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71650-013-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	10/31/2022
2	NDC:71650-013-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	10/31/2022
3	NDC:71650-013-03	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/30/2020	10/31/2022
4	NDC:71650-013-04	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/30/2020	10/31/2022
5	NDC:71650-013-05	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	10/31/2022
6	NDC:71650-013-06	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	10/31/2022
7	NDC:71650-013-07	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	10/31/2022
8	NDC:71650-013-08	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	10/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/30/2020	10/31/2022

Labeler - Global Cosmetics (China) Company Limited (527852739)

Name	Address	ID/FEI	Business Operations
Establishment
Global Cosmetics (China) Company Limited		527852739	manufacture(71650-013)

Revised: 3/2023

Document Id: 211e0e5c-2eb4-4297-8516-4adce2a60ea9

Set id: f8c7553c-fa84-4bef-8d2b-98e3bc12709d

Version: 4

Effective Time: 20230331

Global Cosmetics (China) Company Limited