Xolegel

This medication is used to treat a certain skin condition (seborrheic dermatitis, a type of dandruff). In this condition, it is believed that a fungus (Malassezia furfur) infects the skin or scalp, resulting in dry, flaky skin (scales) on the scalp, face, ears, chest, or upper back. Ketoconazole is an azole antifungal drug that works by stopping the growth of fungus.

Read the Patient Information Leaflet provided by your pharmacist before you start using ketoconazole and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Use this medication on the scalp and skin only. Clean and thoroughly dry the area to be treated. Wash hands before and after applying this medication. Apply it to the affected skin and also to a small amount of the normal skin next to this area, usually once a day or as directed by your doctor. Length of treatment depends on the response to treatment and is usually for 2 weeks. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.

Do not get this medication in the eyes, nose, or mouth. If this occurs, flush with plenty of water. If irritation occurs, contact your doctor right away.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Do not wash the treated area for at least 3 hours after applying this medication. Wait at least 20 minutes before applying makeup or sunscreen to the treated skin.

Tell your doctor if your condition persists or worsens after 2 weeks.

Burning, redness, or dryness of the treated skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these rare but very serious side effects occur: blisters/open sores on the treated skin, eye swelling.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. This product is flammable. Do not store or use near an open flame. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another skin condition unless told to do so by your doctor. A different medication may be necessary in that case.