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Xolegel Duo gel

Generic Name: ketoconazole gel and pyrithione zinc shampoo (KEE-toe-KON-a-zole/PIR-i-THYE-one zink)
Brand Name: Xolegel Duo

Xolegel Duo gel is used for:

Treating and preventing itching, flaking, and scaling of the skin and scalp caused by seborrheic dermatitis and dandruff.

Xolegel Duo gel is a convenience pack containing an antifungal gel and antiseborrheic shampoo. The antifungal works by killing the fungus causing the skin condition. The antiseborrheic works by slowing the production of skin cells, which helps to reduce flakiness.

Do NOT use Xolegel Duo gel if:

  • you are allergic to any ingredient in Xolegel Duo gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xolegel Duo gel:

Some medical conditions may interact with Xolegel Duo gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a condition that covers a large area of the body
  • if you have a weakened immune system, liver problems, or the blood disease porphyria

Some MEDICINES MAY INTERACT with Xolegel Duo gel. Because little, if any, of Xolegel Duo gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Xolegel Duo gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xolegel Duo gel:

Use Xolegel Duo gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • FOR THE GEL: Wash your hands before and right after using Xolegel Duo gel. Spread a thick layer of Xolegel Duo gel onto the affected skin with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it. Do not touch your eyes or nose while you are applying Xolegel Duo gel.
  • Wait for at least 20 minutes after you apply the gel before you apply makeup or sunscreen.
  • Do not wash the area where you applied the gel for at least 3 hours after you apply it.
  • FOR THE SHAMPOO: Shake well before each use. Wet hair thoroughly. Apply the shampoo and work it into a lather. Rinse thoroughly. You may repeat if desired unless your doctor tells you otherwise.
  • For best results, use the shampoo at least 2 times per week or as directed by your doctor. Do not use more often than once daily.
  • IF YOU MISS A DOSE OF THE GEL, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. IF YOU MISS A DOSE OF THE SHAMPOO, use the dose when you remember. Continue to use Xolegel Duo gel as directed by your doctor or the package labeling.

Ask your health care provider any questions you may have about how to use Xolegel Duo gel.

Important safety information:

  • Xolegel Duo gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse at once with cool tap water. Do not get Xolegel Duo gel in your vagina.
  • Check with your doctor before you use Xolegel Duo gel if your condition covers a large area of your body.
  • If your symptoms do not improve with regular use or if they become worse, consult your doctor.
  • Do not use Xolegel Duo gel for other skin conditions at a later time.
  • The gel in this convenience pack is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Xolegel Duo gel.
  • Xolegel Duo gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xolegel Duo gel while you are pregnant. It is not known if this medicine is found in breast milk after topical use. If you are or will be breast-feeding while you use Xolegel Duo gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xolegel Duo gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild burning at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, irritation, pain, redness, or severe burning at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Xolegel Duo gel is harmful if swallowed.

Proper storage of Xolegel Duo gel:

Store Xolegel Duo gel at room temperature, at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do NOT store near an open flame. Keep Xolegel Duo gel out of the reach of children and away from pets.

General information:

  • If you have any questions about Xolegel Duo gel, please talk with your doctor, pharmacist, or other health care provider.
  • Xolegel Duo gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Xolegel Duo gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xolegel Duo gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xolegel Duo gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Xolegel Duo gel.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.