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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.

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

Important information

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 Xolegel 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 using Xolegel

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

FDA pregnancy category C. It is not known whether Xolegel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether ketoconazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. You should not breast-feed if you have applied Xolegel to your breast area.

Do not give this medicine to a child younger than 12 years old without medical advice.

How should I apply Xolegel?

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 Xolegel 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.

What happens if I miss a dose?

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.

What happens if I overdose?

An overdose of Xolegel 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.

What should I avoid?

Avoid getting Xolegel in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash 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.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Xolegel side effects

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

Stop using Xolegel and call your doctor at once if you have a serious side effect such as:

  • severe itching, burning, or irritation where the medicine is applied;

  • oily or dry scalp, mild hair loss;

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

  • eye redness, swelling, or irritation.

Less serious Xolegel side effects include:

  • mild skin itching or irritation;

  • dry skin; or

  • headache.

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.

See also: Side effects (in more detail)

What other drugs will affect Xolegel?

There may be other drugs that can affect Xolegel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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