Ketodan (Ketoconazole): Uses, Side Effects and Dosage

What is Ketodan^® Foam, 2%?

Ketodan^® Foam, 2% is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in people 12 years of age and older with a normal immune system.

It is not known if Ketodan^® Foam, 2% is safe and effective when used to treat fungal infections.

It is not known if Ketodan^® Foam, 2% is safe and effective in children less than 12 years of age.

Before using Ketodan^® Foam, 2%, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Ketodan^® Foam, 2% will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if Ketodan^® Foam, 2% passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Ketodan^® Foam, 2%.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Ketodan^® Foam, 2%?

• Use Ketodan^® Foam, 2% exactly as your healthcare provider tells you to use it. See the detailed "Instructions for Use" at the end of this leaflet for directions about how to apply Ketodan^® Foam, 2% the right way.
• Apply Ketodan^® Foam, 2% to the affected skin area(s) 2 times each day for 4 weeks. You should apply enough Ketodan^® Foam, 2% to cover the entire affected area(s).
• Talk to your healthcare provider if your skin does not improve after 4 weeks of treatment with Ketodan^® Foam, 2%.
• Dispense Ketodan^® Foam, 2% directly into the cap. Do not dispense Ketodan^® Foam, 2% directly onto your hands, because the foam will begin to melt on contact with warm skin.
• Wash your hands after applying Ketodan^® Foam, 2%.

What should I avoid while using Ketodan^® Foam, 2%?

• Ketodan^® Foam, 2% is flammable. Avoid fire, flames, or smoking during and right after you apply Ketodan^® Foam, 2% to your skin.
• Avoid getting Ketodan^® Foam, 2% in or near your eyes, mouth, lips or vagina. If you get Ketodan^® Foam, 2% on your lips or in your eyes, mouth or vagina, rinse well with water.

What are the possible side effects of Ketodan^® Foam, 2%?

Ketodan^® Foam, 2% may cause serious side effects, including:

• Skin irritation at the application area(s), including skin reactions caused by exposure to light. Tell your healthcare provider if you develop skin irritation during treatment with Ketodan^® Foam, 2%.

The most common side effects of Ketodan^® Foam, 2% include, burning, dryness, redness, irritation, numbness, itching, rash and warmth at the application site.

These are not all of the possible side effects of Ketodan^® Foam, 2%.

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

How should I store Ketodan^® Foam, 2%?

• Store Ketodan^® Foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not store the Ketodan^® Foam, 2% can in the refrigerator or freezer.
• Keep Ketodan^® Foam, 2% away from heat. Never throw the Ketodan^® Foam, 2% can into a fire, even if the can is empty.
• Do not store Ketodan^® Foam, 2% at temperatures above 120°F (49°C).
• Do not break through (puncture) the Ketodan^® Foam, 2% can.

Keep Ketodan^® Foam, 2% and all medicines out of the reach of children.

General information about the safe and effective use of Ketodan^® Foam, 2%.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ketodan^® Foam, 2% for a condition for which it was not prescribed. Do not give Ketodan^® Foam, 2% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Ketodan^® Foam, 2% that is written for health professionals.

What are the ingredients in Ketodan^® Foam, 2%?

Active ingredient: ketoconazole

Inactive Ingredients: cetyl alcohol, citric acid, ethanol 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant

For more information, call Medimetriks at 1-973-882-7512

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

Instructions for Use

Ketodan^® Foam, 2%

Important Information: Ketodan^® Foam, 2% is for use on the skin only. Do not use Ketodan^® Foam, 2% in your eyes, mouth or vagina.

Step 1: Remove the clear cap from the Ketodan® Foam, 2% can.
Step 2: Hold the can upright and firmly press the nozzle to dispense Ketodan® Foam, 2% into the clear cap. Dispense enough Ketodan® Foam, 2% to cover the entire affected area(s).
If the can seems warm or the foam seems runny, run the can under cold water.
Step 3: Pick up small amounts of Ketodan® Foam, 2% with your fingertips and gently rub the foam into the affected area(s) until the foam disappears.
If you are treating areas such as your scalp, part the hair so that Ketodan® Foam, 2% may be applied directly to the skin.
Step 4: Wash your hands after applying Ketodan® Foam, 2%. Throw away any of the unused medicine that is left in the cap. How should I store Ketodan® Foam, 2%? Store Ketodan® Foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C). Do not store the Ketodan® Foam, 2% can in the refrigerator or freezer. Keep Ketodan® Foam, 2% away from heat. Never throw the can into a fire, even if the can is empty. Do not store Ketodan® Foam, 2% at temperatures above 120°F (49°C). Do not break through (puncture) the Ketodan® Foam, 2% can. Keep Ketodan® Foam, 2% and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration.