Drug Facts

Active ingredient

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Use Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings For external use only. Flammable. Keep away from flame 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 rash 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 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients glycerin, hydrogen peroxide, purified water USP, fragrance

Manufactured By:

Pure USA, LLC

Richand Hills, TX 76118

MADE IN USA

833-4-MY-PURE

Packaging

PURE USA HAND SANITIZER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80665-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80665-101-75	0.75 L in 1 POUCH; Type 0: Not a Combination Product	09/25/2020
2	NDC:80665-101-15	1.5 L in 1 POUCH; Type 0: Not a Combination Product	09/25/2020
3	NDC:80665-101-03	3 L in 1 POUCH; Type 0: Not a Combination Product	09/25/2020
4	NDC:80665-101-01	3.78 L in 1 JUG; Type 0: Not a Combination Product	09/25/2020
5	NDC:80665-101-05	1 in 1 BOX	09/25/2020
5		5 L in 1 POUCH; Type 0: Not a Combination Product
6	NDC:80665-101-10	1 in 1 BOX	09/25/2020
6		10 L in 1 POUCH; Type 0: Not a Combination Product
7	NDC:80665-101-18	1 in 1 BOX	09/25/2020
7		18 L in 1 POUCH; Type 0: Not a Combination Product
8	NDC:80665-101-55	208.2 L in 1 DRUM; Type 0: Not a Combination Product	09/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/25/2020

Labeler - Pure USA, LLC (117584117)