Alclene Hand Sanitizer by Global Cosmetics (China) Company Limited alclene Hand Sanitizer

Alclene Hand Sanitizer by

Drug Labeling and Warnings

Alclene Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Global Cosmetics (China) Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCLENE HAND SANITIZER- alcohol gel 
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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alclene Hand Sanitizer

Drug Facts

Active Ingredients

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses[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 ash 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 : Aloe Barbadensis Leaf Juice, Carbomer, Citric Acid, Denatonium Benzoate, Glycerin, Triethanolamine, Water (Aqua)

Questions or comments? Emergency Contact Chemtel™ North America: 1-800-255-3924

Kills 99.9% of Germs

With Glycerin and Aloe Vera extracts

Distributor: Nuten Custom Manufacturing Ltd.

1105 Clay Ave, Unit#7, Burlington, ON, L7L 0A1

Made in China

Packaging

ALCLENE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71650-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71650-010-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	08/31/2022
2	NDC: 71650-010-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	08/31/2022
3	NDC: 71650-010-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	08/31/2022
4	NDC: 71650-010-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	08/31/2022
5	NDC: 71650-010-05	1000 mL in 1 POUCH; Type 0: Not a Combination Product	06/20/2020	08/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/20/2020	08/31/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
Global Cosmetics (China) Company Limited		527852739	manufacture(71650-010)

Revised: 3/2023

Document Id: d08714dd-54e3-4bb3-86bb-57aa0403121c

34390-5

Set id: 3b101643-436b-4fc7-adaf-42f06174e6dd

Version: 2

Effective Time: 20230331