ANTIMICROBIAL FOAM FRAGRANCE AND DYE FREE- benzalkonium chloride solution

Antimicrobial Foam Fragrance and Dye Free by

Drug Labeling and Warnings

Antimicrobial Foam Fragrance and Dye Free 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.

Stop use and ask a doctor if

irritation and redness develop and persist for more than 3 days.

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

PRINCIPAL DISPLAY PANEL

Antimicrobial Foam Soap Fragrance & Dye Free

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

deb foam technology

MADE IN USA

Deb USA, Inc.

Charlotte, NC 28217

www.debgroup.com

57156

1 L (33.8 fl oz)

DCN9284

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL FOAM FRAGRANCE AND DYE FREE 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-014
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-014-27	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(11084-014)