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(ketoconazole, 2%) Foam
IMPORTANT: For skin use only. Do not use in the eyes, mouth or vagina.
Read the Patient Information that comes with EXTINA® 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® Foam?
EXTINA® 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® Foam has not been studied in children less than 12 years old.
What should I tell my doctor before using EXTINA® Foam?
For female patients, tell your doctor if you:
- are pregnant or become pregnant. It is not known if EXTINA® Foam can harm a fetus (unborn baby).
- breastfeeding. It is not known if EXTINA® Foam passes into breast milk.
How should I use EXTINA® Foam?
- Apply EXTINA® Foam exactly as prescribed. EXTINA® 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® Foam.
- Keep the EXTINA® Foam can away from and do not spray it near fire, open flame, or direct heat. EXTINA® Foam is flammable. Never throw the EXTINA® Foam can into a fire, even if the can is empty.
Instructions for applying EXTINA® Foam
1. Hold the can at an upright angle.
2. Push the button to spray EXTINA® Foam directly into the cap of the can or other cool surface. Spray only the amount of EXTINA® Foam that you will need to cover your affected skin.
Do not spray EXTINA® Foam directly onto your affected skin or your hands because the foam will begin to melt right away when it touches your skin.
3. If your fingers are warm, rinse them in cold water first. Be sure to dry them well before handling the EXTINA® Foam. If the EXTINA® 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® Foam into the affected areas until the foam disappears.
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® Foam in your eyes, mouth or vagina. If any EXTINA® Foam gets in your eyes, mouth or vagina, rinse areas well with water.
7. Wash your hands well after applying EXTINA® Foam.
What are the possible side effects of EXTINA® Foam?
The most common side effects of EXTINA® 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® Foam. Ask your doctor or pharmacist for more information.
How should I store EXTINA® Foam?
- EXTINA® Foam is flammable.
- Do not spray EXTINA® Foam near fire or direct heat. Never throw the can into a fire, even if the can is empty.
- Store the can of EXTINA® Foam at room temperature, 68° to 77°F (20°-25°C). Do not place the EXTINA® Foam can in the refrigerator or freezer.
- Keep the EXTINA® Foam can away from all sources of fire and heat. Do not leave the EXTINA® Foam can in direct sunlight.
- Do not smoke while holding the EXTINA® Foam can or while spraying or applying the foam.
- Do not pierce or burn the EXTINA® Foam can.
- Keep EXTINA® Foam and all medicines out of the reach of children.
General information about EXTINA® Foam
Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use EXTINA® Foam for any other condition for which it was not prescribed. Do not give EXTINA® 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® Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about EXTINA® Foam that is written for health professionals.
If you have questions about EXTINA® Foam you can also call: 1-866-897-5002 (Prestium). (this is a toll-free number).
What are the ingredients in EXTINA® Foam?
Active ingredients: ketoconazole
Inactive Ingredients: cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.
This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 3/24/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Extina Information
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Report Problems to the Food and Drug Administration
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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