FOAMFRESH HEALTHCARE HAND WASH- chloroxylenol liquid

FoamFresh Healthcare Hand Wash by

Drug Labeling and Warnings

FoamFresh Healthcare Hand Wash 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

Chloroxylenol 0.75%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses:

For hand washing to decrease bacteria on the skin.

WARNINGS

Warnings:

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush eyes 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.

Children must be supervised in use of this product.

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

DOSAGE & ADMINISTRATION

Directions:

For maximum efficacy, pump foam into dry hands, lather vigorously for 30 seconds, rinse and dry.

STORAGE AND HANDLING

Other Information:

Store at 20 to 25 C (68 to 77 F)

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Polysorbate 20, Decyl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol and Fragrance.

PRINCIPAL DISPLAY PANEL

FoamFresh

Healthcare Hand Wash

Fortified with moisturizers, for maximum skin

conditioning. Suitable for everyday use in

medical facilities.

PK

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

www.woodbineproducts.com

Made in the U.S.A.

Stock # 4395         1000 ml (34 fl. oz.)

INGREDIENTS AND APPEARANCE

FOAMFRESH HEALTHCARE HAND WASH 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1008-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/18/2014

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1008)