FOAMFRESH E-2 SANITIZER CLEANSER- benzalkonium chloride liquid

FoamFresh E-2 Sanitizer Cleanser by

Drug Labeling and Warnings

FoamFresh E-2 Sanitizer Cleanser by is a Otc medication manufactured, distributed, or labeled by Woodbine Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.13%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses:

For hand washing to decrease bacteria 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 with water.

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

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions:

Pump a small amount of foam into palm of hand.

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

Rinse with potable water.

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid.

PRINCIPAL DISPLAY PANEL

FoamFresh

E-2 Sanitizer Cleanser

For Food Service and Health Care

For Food Service:

A "one-step" E-2 hand wash to effectively reduce bacteria flora on the skin without need for a prewash.

Contains no perfume, dyes or contaminants to affect food products.

For Health Care:

Mild yet effective hand wash for high risk areas.

Dye and fragrance free formula for frequent hand washings.

Excellent skin compatibility.

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

www.woodbineproducts.com

Made in USA

Stock # 4560                 1000 ml (34 fl. oz.)

FoamFresh E-2 Sanitizer

With Moisturizers

INGREDIENTS AND APPEARANCE

FOAMFRESH E-2 SANITIZER CLEANSER  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1002
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 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1002-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
2	NDC: 11429-1002-7	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
3	NDC: 11429-1002-8	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/26/2014

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1002)