ALCOHOL HAND SANITIZER 80%

ALCOHOL HAND SANITIZER 80% by

Drug Labeling and Warnings

ALCOHOL HAND SANITIZER 80% by is a Otc medication manufactured, distributed, or labeled by Global Cosmetics (China) Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 71650-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71650-013-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/202010/31/2022
2NDC: 71650-013-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/202010/31/2022
3NDC: 71650-013-03100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/30/202010/31/2022
4NDC: 71650-013-04250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/30/202010/31/2022
5NDC: 71650-013-05250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/30/202010/31/2022
6NDC: 71650-013-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/30/202010/31/2022
7NDC: 71650-013-071000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/30/202010/31/2022
8NDC: 71650-013-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/202010/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/30/202010/31/2022
Labeler - Global Cosmetics (China) Company Limited (527852739)
Establishment
NameAddressID/FEIBusiness Operations
Global Cosmetics (China) Company Limited527852739manufacture(71650-013)

Revised: 3/2023
 

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