Utopic

There are many brands and forms of urea topical available, and not all are included in this leaflet.

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

Utopic may also be used for other purposes not mentioned in this medication guide.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you take.

You should not use Utopic if you are allergic to it.

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

It is not known if 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; difficulty breathing; swelling of your face, lips, tongue, or throat.

Utopic may cause serious side effects. Stop using Utopic and call your doctor right away if you have:

• severe redness or irritation of treated skin.

Common side effects of Utopic may include:

• mild itching; or
• mild burning or stinging.

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

Utopic 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. Utopic 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. Utopic 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 Utopic 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 Utopic 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 Utopic.

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.

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

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

Do not use Utopic on open wounds, burns, or swollen skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

It is not likely that other drugs you take by mouth or inject will affect urea topical. However, many drugs can interact with each other. Make sure to inform all your health care providers about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.