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Remeven

Generic Name: urea
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

Rx only

For external use only.
Not for ophthalmic use.

Remeven 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:

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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:

Remeven - 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.

Remeven 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 is Remeven Supplied

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

142g (5 oz) tube 58980-680-50
255g (9 oz) tube 58980-680-90

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

Remeven 
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-680
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (Urea) Urea 71 g  in 142 g
Inactive Ingredients
Ingredient Name Strength
Edetate Disodium  
Glycerin  
Lactic Acid  
Mineral Oil  
Water  
Sodium Hydroxide  
Stearic Acid  
Pyrithione Zinc  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:58980-680-50 1 TUBE (TUBE) in 1 BOX
1 142 g in 1 TUBE
2 NDC:58980-680-90 1 TUBE (TUBE) in 1 BOX
2 255 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/18/2008
Labeler - Stratus Pharmaceuticals, Inc (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Revised: 05/2011
 
Stratus Pharmaceuticals, Inc
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