HAND SANITIZER - alcohol gel
Artec Chemical 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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Drug Fact

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antibacterial

Uses

Hand Sanitizer help to kill most of the common germs that may cause diseases

Warning

Wet hand thoroughly with product briskly. Rub hands together until dry. Do not wash off after use

Keep out of reach of children.

Supervise children in the use of this product

Directions

Wet hand thoroughly with product briskly. Rub hands together until dry. Do not wash off after use

INACTIVE INGREDIENT

Aqua (Water), Carbomer, DMDM Hydantoin, Fragrance, Triclosan, Trolamine

phot of druglisting

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76352-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TRICLOSAN (UNII: 4NM5039Y5X)
LACTOSE (UNII: J2B2A4N98G)
TROLAMINE (UNII: 9O3K93S3TK)
DMDM HYDANTOIN (UNII: BYR0546TOW)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76352-002-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2014	05/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/14/2014	05/08/2017

Labeler - Artec Chemical Company Limited (421271074)

Registrant - Artec Chemical Company Limited (421271074)

Name	Address	ID/FEI	Business Operations
Establishment
Artec Chemical Company Limited		421271074	manufacture(76352-002)

Revised: 5/2017

Document Id: 4052ef33-01b1-42ae-81e4-2598bcdb1cd5

Set id: b8485121-81b6-4c6c-811a-1357ffd0c4bc

Version: 2

Effective Time: 20170508

Artec Chemical Company Limited