Urea

Stratus Pharmaceuticals, Inc

UREA 10% CREAM

FULL PRESCRIBING INFORMATION: CONTENTS*

• UREA DESCRIPTION
• CLINICAL PHARMACOLOGY
  • PHARMACOKINETICS
• INDICATIONS AND USES
• UREA CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • PREGNANCY
  • NURSING MOTHERS
• UREA ADVERSE REACTIONS
• UREA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 85g Tube Carton

FULL PRESCRIBING INFORMATION

For external use only.
Not for ophthalmic use.

UREA 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.

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.

UREA 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.

UREA ADVERSE REACTIONS

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

UREA 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.

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