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Ketoconazole (Topical) (Foam, Gel/Jelly)

(EXTINA)
Ketoconazole (On the skin)
Ketoconazole (kee-toe-KON-a-zole)Treats seborrheic dermatitis (scaly areas on your skin or scalp).
Extina , Ketodan Kit , Xolegel

When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to ketoconazole.

How to Use This Medicine:
Foam, Gel/Jelly

  • Your doctor will tell you how much medicine to use. Do not use more than directed.
  • 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 you use 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.

Drugs and Foods to Avoid:

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


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 to treat a skin problem your doctor has not examined.
  • 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. Wear sunscreen. Do not use sunlamps or tanning beds.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
  • Call your doctor if your symptoms do not improve or if they get worse.

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.

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