UREA- urea cream 
Stratus Pharmaceuticals, Inc

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.

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UREA 10% CREAM

For external use only.
Not for ophthalmic use.

DESCRIPTION

UREA 10% CREAM is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails.

Each gram of UREA 10% CREAM contains 10% Urea in a cream base of Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum.

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, UREA 10% 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 UREA 10% 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 UREA 10% 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

UREA 10% CREAM is supplied in:

85g (3 oz) tube      58980-605-30

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

Manufactured by:
 
Sonar Products Inc.
Carlstadt, NJ 07072
Manufactured for:
 
Stratus Pharmaceuticals Inc
Miami, Florida 33186-6727
Telephone: 800-442-7882
www.stratuspharmaceuticals.com

P-UC(10)-201004

PRINCIPAL DISPLAY PANEL - 85g Tube Carton

NDC 58980-605-30
Net WT. 3 oz. (85g)

UREA 10% CREAM

STRATUS
PHARMACEUTICALS INC

Softens and Moisturizes Severe Dry Skin

Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 85g Tube Carton
UREA 
urea cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:58980-605
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (Urea) Urea8.5 g  in 85 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-605-301 in 1 BOX
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/01/2010
Labeler - Stratus Pharmaceuticals, Inc (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Sonar Products, Inc104283945MANUFACTURE

Revised: 4/2010
Document Id: 4870b185-38b8-47cf-a816-f6a4d661b179
Set id: 1aa99ac0-a9fa-4895-9229-df490453d9fd
Version: 1
Effective Time: 20100422
 
Stratus Pharmaceuticals, Inc