HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Open Book Extracts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 73% 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

Flammable. Keep away from fire or flame.

Purpose

For external use only.

Do Not Use

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

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 in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin, Hydroxypropyl Cellulose, Tert Butanol, Methanol, Acetaldehyde, 2-Propanol

Package Label - Principal Display Panel

1.2 mL Single Use Hand Sanitizer

NDC: 75091-2020-1

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75091-2020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.876 mL  in 1.2 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.03 mL  in 1.2 mL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)	0.013 mL  in 1.2 mL
WATER (UNII: 059QF0KO0R)	0.277 mL  in 1.2 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75091-2020-1	1 mL in 1 POUCH; Type 0: Not a Combination Product	04/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/21/2020

Labeler - Open Book Extracts (117239295)

Registrant - Open Book Extracts (117239295)

Establishment
Name	Address	ID/FEI	Business Operations
Open Book Extracts		117239295	manufacture(75091-2020)