Ketoconazole (On the skin)

When This Medicine Should Not Be Used

How to Use This Medicine

Foam, Gel/Jelly

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer to the affected area and the healthy skin right around the affected area. Rub it in gently.
• If you are using the foam:
  • Do not spray it directly on your hand because it will begin to melt as soon as it touches your skin. Instead, spray the foam into the cap of the medicine can or other cool surface. Then dip your fingertips into the foam to pick up small amounts of the medicine, and apply to the affected skin areas. Gently massage the foam into your skin until it disappears.
  • If you are treating skin areas with hair, such as your scalp, move any hair away so the foam can be applied directly to the affected skin.
  • Do not wash the areas where you applied this medicine for at least 3 hours after you apply it.
  • This medicine is flammable. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the foam can.
• If you are using the gel:
  • Cosmetics (makeup or sunscreens) may be put on the affected areas 20 minutes after you apply the medicine.
  • This medicine is flammable. Do not use it near heat, an open flame, or while smoking.

If a dose is missed:

• If you miss a dose or forget to use your medicine, apply it as soon as you can. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not apply extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used medicine container and any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Ketoconazole (kee-toe-KON-a-zole)

Treats seborrheic dermatitis (scaly areas on your skin or scalp).

Brand Name(s)

Extina, Xolegel

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, planning to become pregnant, or breastfeeding.
• Do not use this medicine for a skin problem that has not been checked by your doctor.
• Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• If your symptoms do not improve or if they get worse, call your doctor.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Burning where you applied the medicine.
• Eye irritation, dryness, swelling, or redness.
• Numbness, prickling, "pins and needles", or tingling feelings.
• Skin rash, discharge, swelling, dryness, redness, itching, pain, or blisters.
• Swelling of the face.

If you notice these less serious side effects, talk with your doctor:

• Acne.
• Dizziness.
• Headache.
• Nail discoloration.