ANTIBACTERIAL FOAM- benzalkonium chloride solution

Antibacterial Foam by

Drug Labeling and Warnings

Antibacterial Foam by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

BENZALKONIUM CHLORIDE 0.13%

Purpose

Antibacterial

Uses

For handwashing to reduce bacteria on the skin

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact, flush with water.

Keep out of reach of children.

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

Directions

Apply foaming cleanser to dry hands
Rub hands together to spread lather
Wash for 15-20 seconds
Rinse & dry hands thoroughly

Inactive ingredients

Aqua (Water), Glycerin, Lauramine Oxide, Butylene Glycol, Lactic Acid, Salicylic Acid, Parfum (Fragrance), Green 5 (CI 61570), Yellow 5 (CI 19140).

PRINCIPAL DISPLAY PANEL

CHEMSTAR

Antibacterial Foam Soap

Ideal for use where antibacterial action is desired.

A high-quality, foam soap that is 99.99% effective against common bacteria.

CHEMSTAR

Integrated Food Safety Solutions

120 Interstate West Parkway

Suite 100

Lithia Springs, GA 30122

800-327-0777

58252

1 Liter (33.8 fl oz)

Rev 0217

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAM 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LACTIC ACID (UNII: 33X04XA5AT)
SALICYLIC ACID (UNII: O414PZ4LPZ)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-013-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2017

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-013)