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Extina

PATIENT INFORMATION

Extina (ketoconazole foam, 2%) (ex-TEEN-ah) Foam
(ketoconazole, 2%)

IMPORTANT: For skin use only. Do not use in the eyes, mouth or vagina.
Read the Patient Information that comes with Extina (ketoconazole foam, 2%) Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Extina (ketoconazole foam, 2%) Foam?

Extina (ketoconazole foam, 2%) Foam is used on the skin (topical) to treat a skin condition called seborrheic dermatitis in patients 12 years and older. Seborrheic dermatitis can cause areas of flaky skin (scales) on the scalp, face, ears, chest or upper back.

Extina (ketoconazole foam, 2%) Foam has not been studied in children less than 12 years old.

What should I tell my doctor before using Extina (ketoconazole foam, 2%) Foam?

For female patients, tell your doctor if you:

  • are pregnant or become pregnant. It is not known if Extina (ketoconazole foam, 2%) Foam can harm a fetus (unborn baby).
  • breastfeeding. It is not known if Extina (ketoconazole foam, 2%) Foam passes into breast milk.

How should I use Extina (ketoconazole foam, 2%) Foam?

  • Apply Extina (ketoconazole foam, 2%) Foam exactly as prescribed. Extina (ketoconazole foam, 2%) Foam is usually applied to the affected skin areas two times a day (once in the morning and once at night) for 4 weeks. Talk to your doctor if your skin does not improve after 4 weeks of treatment with Extina (ketoconazole foam, 2%) Foam.
  • Keep the Extina (ketoconazole foam, 2%) Foam can away from and do not spray it near fire, open flame, or direct heat. Extina (ketoconazole foam, 2%) Foam is flammable. Never throw the Extina (ketoconazole foam, 2%) Foam can into a fire, even if the can is empty.

Instructions for applying Extina (ketoconazole foam, 2%) Foam

  1. Hold the can at an upright angle.

Instructions for applying Extina Foam - illustration 1 2. Push the button to spray Extina (ketoconazole foam, 2%) Foam directly into the cap of the can or other cool surface. Spray only the amount of Extina (ketoconazole foam, 2%) Foam that you will need to cover your affected skin.
Do not spray Extina (ketoconazole foam, 2%) Foam directly onto your affected skin or your hands because the foam will begin to melt right away when it touches your skin.

Instructions for applying Extina Foam - illustration 2 3. If your fingers are warm, rinse them in cold water first. Be sure to dry them well before handling the Extina (ketoconazole foam, 2%) Foam. If the Extina (ketoconazole foam, 2%) Foam can seems warm or the foam seems runny, place the can under cool running water for a few minutes.

  4. Using your fingertips, gently massage Extina (ketoconazole foam, 2%) Foam into the affected areas until the foam disappears.

Instructions for applying Extina Foam - illustration 3 5. If you are treating skin areas with hair such as your scalp, move any hair away so that the foam can be applied to the affected skin.

  6. Do not get Extina (ketoconazole foam, 2%) Foam in your eyes, mouth or vagina. If any Extina (ketoconazole foam, 2%) Foam gets in your eyes, mouth or vagina, rinse areas well with water.

Instructions for applying Extina Foam - illustration 4 7. Wash your hands well after applying Extina Foam.

What are the possible side effects of Extina (ketoconazole foam, 2%) Foam?

The most common side effects of Extina (ketoconazole foam, 2%) Foam are reaction or burning on treated skin areas. Tell your doctor if you have any reaction on your treated skin such as redness, itching, or a rash. These are not all the side effects of Extina (ketoconazole foam, 2%) Foam. Ask you doctor or pharmacist for more information.

How should I store Extina (ketoconazole foam, 2%) Foam?

  • Extina (ketoconazole foam, 2%) Foam is flammable.
  • Do not spray Extina (ketoconazole foam, 2%) Foam near fire or direct heat. Never throw the can into a fire, even if the can is empty.
  • Store the can of Extina (ketoconazole foam, 2%) Foam at room temperature, 68 to 77°F (20-25°C). Do not place the Extina (ketoconazole foam, 2%) Foam can in the refrigerator or freezer.
  • Keep the Extina (ketoconazole foam, 2%) Foam can away from all sources of fire and heat. Do not leave the Extina (ketoconazole foam, 2%) Foam can in direct sunlight.
  • Do not smoke while holding the Extina (ketoconazole foam, 2%) Foam can or while spraying or applying the foam.
  • Do not pierce or burn the Extina (ketoconazole foam, 2%) Foam can.
  • Keep Extina (ketoconazole foam, 2%) Foam and all medicines out of the reach of children.
General information about Extina (ketoconazole foam, 2%) Foam

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Extina (ketoconazole foam, 2%) Foam for any other condition for which it was not prescribed. Do not give Extina (ketoconazole foam, 2%) Foam to other people, even if they have the same condition that you have. It may harm them.

This leaflet summarizes the most important information about Extina (ketoconazole foam, 2%) Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Extina (ketoconazole foam, 2%) Foam that is written for health professionals.

If you have questions about Extina (ketoconazole foam, 2%) Foam you can also call: 1-888-500-DERM (this is a toll-free number) between 6:00 a.m. and 4:00 p.m. Pacific Standard Time, Monday through Friday.

What are the ingredients in Extina (ketoconazole foam, 2%) Foam?

Active ingredients: ketoconazole, USP

Inactive Ingredients: cetyl alcohol NF, citric acid USP, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60 NF, potassium citrate USP, propylene glycol USP, purified water USP, and stearyl alcohol NF pressurized with a hydrocarbon (propane/butane) propellant.

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The Patient Information leaflet was last revised: June 2007

Last reviewed on RxList: 7/9/2007
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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