HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by STUDIO 320, Open Book Extracts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 73%.

Purpose

Antiseptic

Use

Reduces bacteria on skin. Use when soap and water are not available.

Warnings

Flammable. Keep away from flame.

Purpose

For external use only. If swallowed, seek medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Do Not Use

Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if rash appears.

Directions

Bend where indicated on package to dispense. Squeeze contents into hands and rub together until dry.

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

Just Hand Sanitizer box

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78065-2020
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: 78065-2020-2	100 in 1 BOX	05/21/2020
1		1.2 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 78065-2020-1	1.2 mL in 1 POUCH; Type 0: Not a Combination Product	05/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/21/2020

Labeler - STUDIO 320 (066376564)

Registrant - Open Book Extracts (117239295)

Establishment
Name	Address	ID/FEI	Business Operations
Open Book Extracts		117239295	manufacture(78065-2020)