ARTEC MED ANTIBACTERIAL HAND SANITIZER- alcohol solution
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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Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

Flammable. Keep away from fire and flame

For external use only.

When using this product, avoid contact with eyes. In case of contact, flush eyes thoroughly with water

Stop use and ask a doctor if irritation or redness develops

Keep out of reach of children

Directions

Apply suitable amount of product in your palm and spread thoroughly on both hands. Rub onto skin until dry

Other information

Store below 105F

Inactive ingredients

Water, Glycerin, Parfum, Aloe Barbadensis Leaf Juice, Hydrogen Peroxide, Triethanolamine, Tocopheryl Acetate

image description

ARTEC MED ANTIBACTERIAL HAND SANITIZER
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76352-101
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76352-101-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
2	NDC:76352-101-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
3	NDC:76352-101-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
4	NDC:76352-101-04	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
5	NDC:76352-101-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
6	NDC:76352-101-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
7	NDC:76352-101-07	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/15/2020

Labeler - Artec Chemical Company Limited (421271074)

Name	Address	ID/FEI	Business Operations
Establishment
Artec Chemical Company Limited		421271074	manufacture(76352-101)