AMERICAN HAND SANITIZER- benzalkonium chloride spray

American Hand Sanitizer by

Drug Labeling and Warnings

American Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by American Hand Sanitizer, LLC, Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

PURPOSE

Anitseptic

INDICATIONS & USAGE

For hand sanitizing to decrease bacteria and viruses on the skin.

Recommended for repeated use.

WARNINGS

Warnings

For external use only.

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop it and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Read the entire label before using this product.

Pump a small amount of liquid into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

INACTIVE INGREDIENT

Glycerin, Hydrogen Peroxide, Water

QUESTIONS

Questions?

1-866-443-4509

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMERICAN HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79421-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79421-001-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2017

Labeler - American Hand Sanitizer, LLC (117295138)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(79421-001)