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

Antiseptic

Uses

To decrease bacteria on the skin.

Warning

For external use only.
When using this product avoid contact with eyes.In case of contact flush eyes thoroughly with water.

Flammable.
Keep away from heat and flame.

Stop use and consult a doctor
if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children.

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

Directions

■ Wet hands with product and allow to dry without wiping.

Children under 6 years of age should be supervised when using this product.

Other Information

do not store above 104F (40C)
may discolor certain fa surfaces.

Inactive Ingredient

WATER,PHENOXYETHANOL,CARBOMER COPOLYMER TYPE A,SODIUM HYDRIDE,DMDM HYDANTOIN ,FD&C BLUE NO. 1,FD&C YELLOW NO. 5

phot of druglisting image description

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76352-003
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	red, pink, green, orange, purple, blue	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76352-003-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2015	05/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/17/2015	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(76352-003)

Revised: 5/2017

Document Id: 82a089d5-ee8a-4cd7-985f-650e4a14cdc2

Set id: 7087d923-dac6-4e9c-b07a-571aef096281

Version: 2

Effective Time: 20170508

Artec Chemical Company Limited