RE-U40 Foam

Name: RE-U40 Foam

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
(web3)