Patient Information

Xolegel® (Ketoconazole, USP) Gel, 2%



Read the Patient Information that comes with Xolegel Gel carefully 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 health care provider. If you have any questions about Xolegel Gel, ask your healthcare provider.

Xolegel Gel is a prescription medicine used on the skin (topical) to treat a condition called seborrheic dermatitis. Patients with seborrheic dermatitis can have areas of dry, flaky skin (scales) on the scalp, face, ears, chest or upper back.

Xolegel Gel should only be used by patients with a normal immune system. Xolegel Gel has not been studied in children below the age of 12.

What should I tell my health care provider before using Xolegel Gel?

  • Tell your health care provider about all of your medical conditions, including if you are pregnant or planning to become pregnant. It is not known if Xolegel Gel can harm your unborn baby. Xolegel Gel should be used during pregnancy only if needed. It is not known if Xolegel Gel passes into your breast milk or if it can harm your baby.
  • Tell your health care provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. It is not known if Xolegel Gel and other medicines can affect each other. Know the medicines you take. Keep a list of your medicines, and show it to your health care provider and pharmacist when you get a new medicine.

How should I use Xolegel Gel?

  • Use Xolegel Gel exactly as prescribed. Talk to your health care provider if your condition gets worse or does not get better by the end of your treatment.
  • Stay away from fire, flame or smoking while you are applying Xolegel Gel and right after you apply it.
  • Wash your hands before and after applying Xolegel Gel.
  • Spread a thin layer of Xolegel Gel evenly on the affected skin with your fingertips. Be sure to cover all affected areas and the healthy skin right around the affected area.
  • Do not wash the areas where you applied Xolegel Gel for at least three hours after you apply it.
  • Wait at least 20 minutes after you spread Xolegel Gel on your skin before you put makeup or sunscreen on the affected areas.
  • Use Xolegel Gel once daily for two weeks. Your skin may remain improved after you stop using Xolegel Gel.
What should I avoid while using Xolegel Gel?
  • Stay away from fire, flame or smoking while you are applying Xolegel Gel and right after you apply it.
  • Do not touch your eyes or nose while you are applying Xolegel Gel. Wash your hands well after you apply it. Irritation may occur if you get Xolegel Gel in your eyes or nose.
What are the possible side effects of Xolegel Gel?
  • Stop using Xolegel Gel, and talk to your health care provider if you have itching and a rash.
  • The most common side effect is a burning feeling where Xolegel Gel is applied.

These are not all of the side effects of Xolegel Gel. For more information, ask your health care provider or pharmacist.

How should I store Xolegel Gel?
  • Store Xolegel Gel at 59ºF to 86ºF (15º to 30ºC).
  • Keep Xolegel Gel and all medicines out of the reach of children.
General information about Xolegel Gel

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Xolegel Gel for a condition for which it was not prescribed. Do not give Xolegel Gel to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about Xolegel Gel. If you would like more information, talk with your health care provider. You can ask your pharmacist or health care provider for information about Xolegel Gel that is written for health professionals. For additional information on Xolegel Gel, visit www.Xolegel.com or call Barrier Therapeutics, Inc. customer service at 1-866-440-5508.

What are the ingredients in Xolegel Gel?

Active ingredient: ketoconazole

Inactive ingredients: dehydrated alcohol USP, ascorbic acid USP, butylated hydroxytoluene NF, citric acid monohydrate USP, glycerin USP, hydroxypropyl cellulose NF, polyethylene glycol 400 NF, PPG-15 stearyl ether, propylene glycol USP, FD&C yellow No. 6, D&C Yellow No. 10.

Distributed By:

Barrier Therapeutics, Inc.
600 College Road East
Princeton, NJ 08540-6697
www.barriertherapeutics.com
1-866-440-5508
US Patent Numbers 09/562, 376 and
10/722,134 (Patents Pending)
February 2008
XO-8001