Moisturizing Hand Sanitizer Gel by IMEI CHEMICAL ENTERPRISE LTD. IMEI 2nd submital 202-02

Moisturizing Hand Sanitizer Gel by

Drug Labeling and Warnings

Moisturizing Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by IMEI CHEMICAL ENTERPRISE LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MOISTURIZING HAND SANITIZER GEL- alcohol gel 
IMEI CHEMICAL ENTERPRISE LTD.

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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IMEI 2nd submital 202-02

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

Be used on the hands without water as a cleansing

Warnings

For external use only, do not inhale or ingest

Flammable keep away from fireor flame or direct sunlight

When using the product keep out of eyes. In case of eye contact, flush thoroughly with water and get medical help

Stop use and ask a doctor if skin irritation develops.

For children under 6, use only under adult supervision. Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

After washing your hand, spray product on your palm to thoroughly cover your hand, rub hands together for 10 to 15 seconds until dry. Use as needed.

Other information

Do not store above 105F/40C. Store in a cool dry place, away for direct sunlight.

Inactive ingredients

Water, Carbomer, Triethanolamine, Polysorbate 20, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid

Package Label - Principal Display Panel

2000 mL NDC: 77660-202-02

MOISTURIZING HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77660-202
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
HYALURONIC ACID (UNII: S270N0TRQY)
CARBOMER 1342 (UNII: 809Y72KV36)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ECAMSULE DITRIETHANOLAMINE (UNII: 078Q44I6CD)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77660-202-02	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020	07/13/2021

Labeler - IMEI CHEMICAL ENTERPRISE LTD. (657454100)

Establishment
Name	Address	ID/FEI	Business Operations
IMEI CHEMICAL ENTERPRISE LTD.		657454100	manufacture(77660-202)

Revised: 7/2021

Document Id: c70633b1-5246-03ca-e053-2995a90af861

34390-5

Set id: a96b1e97-75c5-1ed1-e053-2995a90a93ac

Version: 2

Effective Time: 20210713