REMEVEN™ CREAM (Urea 50% in a cream base)

REMEVEN - urea cream 
Stratus Pharamceuticals, Inc

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REMEVEN™ CREAM
(Urea 50% in a cream base)

Rx only

For external use only.
Not for ophthalmic use.

DESCRIPTION

REMEVEN™ CREAM is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.

Each gram of REMEVEN™ CREAM contains:

ACTIVE: 50% Urea in a cream base of:

INACTIVES:Acrylates Copolymer, Carbomer, dl - Alphatocopheryl Acetate, Disodium EDTA, Glycerine, Lactic Acid, Mineral Oil, Polysorbate 85, Purified Water, Sodium Hydroxide, Stearic Acid and Zinc Pyrithione.

CHEMISTRY

Urea is a diamide of carbonic acid with the following chemical structure:

Chemical Structure

CLINICAL PHARMACOLOGY

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS

The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS

If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PREGNANCY

Pregnancy Category B

Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, REMEVEN™ CREAM should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when REMEVEN™ CREAM is administered to a nursing woman.

ADVERSE REACTIONS

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

DOSAGE AND ADMINISTRATION

Apply REMEVEN™ CREAM to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

HOW SUPPLIED

REMEVEN™ CREAM (50% Urea) is supplied in:

142g (5 oz) tube58980-680-50
255g (9 oz) tube58980-680-90

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

Distributed by:
Stratus Pharmaceuticals Inc,
Miami, Florida 33186-6727
Tollfree:800-442-7882
www.stratuspharmaceuticals.com

Manufactured by:
Sonar Products, Inc., Carlstadt, NJ 07072

JG-RC-IN 2007-07

PRINCIPAL DISPLAY PANEL - 142 g Carton

NDC 58980-680-50
NET WT 5.0 oz (142g)

REMEVEN™ CREAM
(50% UREA IN A CREAM BASE)

STRATUS
PHARMACEUTICALS INC

Rx only

Manufactured for Stratus Pharmaceuticals Inc., 14377 SW 142nd Street, Miami, Florida 33186

Principal Display Panel - 142 g Carton

REMEVEN 
urea   cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)58980-680
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (Urea) Urea71 g  in 142 g
Inactive Ingredients
Ingredient NameStrength
Edetate Disodium 
Glycerin 
Lactic Acid 
Mineral Oil 
Water 
Sodium Hydroxide 
Stearic Acid 
Pyrithione Zinc 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
158980-680-501 TUBE In 1 BOXcontains a TUBE
1142 g In 1 TUBEThis package is contained within the BOX (58980-680-50)
258980-680-901 TUBE In 1 BOXcontains a TUBE
2255 g In 1 TUBEThis package is contained within the BOX (58980-680-90)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/18/2008

Labeler - Stratus Pharamceuticals, Inc (789001641)
Registrant - Sonar Products, Inc (104283945)
Establishment
NameAddressID/FEIOperations
Sonar Products, Inc104283945MANUFACTURE
Revised: 12/2009Stratus Pharamceuticals, Inc