Ure-K

There are many brands and forms of urea topical available and not all brands are listed on this leaflet.

Urea topical (for the skin) is used to soften rough or dry skin caused by skin conditions such as eczema, psoriasis, keratosis, and others. Urea topical is also used to soften damaged fingernails or toenails so they can be removed without surgery.

Urea topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use urea topical if you are allergic to it.

FDA pregnancy category C. It is not known whether urea topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether urea topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using urea topical and call your doctor at once if you have:

• severe redness or irritation of treated skin.

Common side effects may include:

• mild itching; or
• mild burning or stinging.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Urea topical is available in many different forms (cream, lotion, ointment, liquid, gel, foam, shampoo, and others) for use on the skin or the scalp. Use your medicine exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Urea topical is for use only on the skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Use a mild soap or cleanser to wash the skin or nail area to be treated. Urea topical may work best if the skin or nail to be treated is left slightly damp before the medicine is applied.

Apply a thin layer of this medicine to the affected skin and rub it in as completely as possible.

When applying urea topical to the nails, avoid getting any medicine on the cuticles or surrounding skin. Apply generously to the nail and allow the medicine to dry. You may cover the nail with a bandage or gauze if your doctor advises. The treated nail should be easily removed after several days.

Shake the urea topical foam well just before each use. Other forms of this medicine may also need to be shaken before use. Follow all directions on th medicine label.

Wash your hands with soap and water after applying this medicine, unless you are treating the skin on your hands.

Call your doctor if your symptoms do not improve, or if they get worse while using urea topical.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine container tightly closed when not in use.

Keep the foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty foam canister.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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.

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, URE-K™ 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 URE-K™ CREAM is administered to a nursing woman.

NDC 70350-2600-5
URE-K 50% Cream
(50% UREA In A Cream Base)
Net WT. 5.0 oz (142 g)
Rx Only