RE-U40 Foam

Name: RE-U40 Foam

RE-U40 Foam re-u40 foam dosage
RE-U40 Foam drug

RE-U40 Foam Description

RE-U40 Foam is a keratolytic emollient in a water and lipid-based foam which is a gentle, but potent, tissue softener for skin and nails.

RE-U40 Foam contains the active ingredient: Urea 40%. The inactive ingredients are: Carbomer, Colloidal Oatmeal, Dimethicone, Ethylparaben, Glycerine, Laureth 4, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylparaben, Propylene Glycol, Purified Water, Stearic Acid and Triethanolamine and in propellants Butane and Propane.

RE-U40 Foam - Clinical Pharmacology

Urea, topically applied, dissolves the intercellular matrix of the skin which can result in enhanced shedding of scaly, dry skin which causes a softening of the hyperkeratotic areas of the skin. Applied to the nail plate topically, urea has a similar effect on the intercellular matrix of the nail plate.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings

RE-U40 Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips and all mucous membranes should be avoided. RE-U40 Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.

RE-U40 Foam Dosage and Administration

Unless otherwise directed by a prescribing physician, RE-U40 Foam should be applied to affected area twice a day. RE-U40 Foam should be rubbed into the skin until it is completely absorbed.

Packaging

UREA
urea aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:68032-354
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	400 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 1342
OATMEAL
DIMETHICONE
ETHYLPARABEN
GLYCERIN
LAURETH-4
METHYLPARABEN
PHENOXYETHANOL
POLYSORBATE 20
PROPYLPARABEN
PROPYLENE GLYCOL
WATER
STEARIC ACID
TROLAMINE
BUTANE
PROPANE

Packaging
#	Item Code	Package Description
1	NDC:68032-354-15	150 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2009	06/30/2011

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010 River's Edge Pharmaceuticals, LLC