HAND SANITIZER - ETHANOL- alcohol liquid

Hand Sanitizer - Ethanol by

Drug Labeling and Warnings

Hand Sanitizer - Ethanol by is a Otc medication manufactured, distributed, or labeled by Benet Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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 heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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.

STOP USE

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

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

Hand Sanitizer - Topical Antiseptic Hand Sanitizer Label 1 Gallon

3785 mL NDC: 76779-0001-1

Hand Sanitizer 1 Gallon.jpg

946 mL NDC: 76779-0001-2

Hand Sanitizer 1 Quart.jpg

INGREDIENTS AND APPEARANCE

HAND SANITIZER - ETHANOL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76779-0001(NDC:65353-4934)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76779-0001-1	3785.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
2	NDC: 76779-0001-2	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
3	NDC: 76779-0001-3	473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Benet Incorporated (104989944)

Registrant - Benet Incorporated (104989944)

Establishment
Name	Address	ID/FEI	Business Operations
Benet Incorporated		104989944	repack(76779-0001)