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

Gormel 10 (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.

Gormel 10 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.

Gormel 10 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. Gormel 10 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. Gormel 10 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 Gormel 10 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 Gormel 10 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 Gormel 10.

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.

You should not use Gormel 10 if you are allergic to it.

FDA pregnancy category C. It is not known whether Gormel 10 will harm an unborn baby. Do not use Gormel 10 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.

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.

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

Do not use Gormel 10 on open wounds, burns, or areas of swollen skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

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.

Gormel 10 may cause serious side effects. Stop using Gormel 10 and call your doctor at once if you have:

• severe redness or irritation of treated skin.

Common side effects of Gormel 10 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.