Xolegel contains ketoconazole, an antifungal medication that prevents fungus from growing on your skin.

Xolegel is used on the skin to treat seborrheic dermatitis in adults and children 12 years of age and older who have a normal (healthy) immune system. The gel is applied once daily for 14 days. Patients with seborrheic dermatitis can have areas of dry, flaky skin (scales) on the scalp, face, ears, chest or upper back.

The safety and effectiveness of using Xolegel for the treatment of fungal infections has not been established.

You should not use Xolegel if you are allergic to ketoconazole.

Use Xolegel for the full prescribed length of time. Your symptoms may improve before the condition is completely cleared.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Avoid getting this medication in your eyes, nose, or mouth.

Stop using this medicine and call your doctor if you have severe burning, irritation, redness, pain, or oozing where the medicine is applied.

Xolegel gel is flammable. Do not use it while you are smoking or near an open flame.

Do not use this medication on a child younger than 12 years old.

Before taking this medicine

Ask a doctor or pharmacist if Xolegel is safe to use if you have:

• asthma or a sulfite allergy;

• an allergic reaction to an antifungal medicine, such as clotrimazole, econazole, or miconazole.

Ask a doctor before using this medicine if you are pregnant.

You should not breast-feed while using Xolegel.

Always follow directions on the medicine label about using this medicine on a child.

Use Xolegel exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use Xolegel to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Spread a thin layer of Xolegel evenly on the affected skin with your fingertips. Be sure to cover all affected areas. The normal dose is to apply the gel once daily for 2 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying Xolegel.

Avoid being near fire, flame, or smoking during and immediately following application of the gel.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the condition is completely cleared.

Store Xolegel at room temperature away from moisture and heat.

Xolegel gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Ask a doctor or pharmacist if Xolegel is safe to use if you have:

• asthma or a sulfite allergy;

• an allergic reaction to an antifungal medicine, such as clotrimazole, econazole, or miconazole.

Ask a doctor before using this medicine if you are pregnant.

You should not breast-feed while using Xolegel.

Always follow directions on the medicine label about using this medicine on a child.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

An overdose of ketoconazole topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Do not get this medicine in your eyes. If contact does occur, rinse with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn't allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

You may need to avoid sunlight if you are treating pityriasis. Follow your doctor's instructions.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with Xolegel unless your doctor tells you to.

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

Call your doctor at once if you have:

• burning, stinging, or severe irritation after using this medicine;

• redness, pain, or oozing of treated skin; or

• shortness of breath.

Common Xolegel side effects may include:

• thinning hair;

• changes in the color or texture of your hair;

• dry skin; or

• mild itching.

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.