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Ketoconazole gel and pyrithione zinc shampoo gel

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

Ketoconazole gel and pyrithione zinc shampoo gel is used for:

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

Ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel if:

  • you are allergic to any ingredient in ketoconazole gel and pyrithione zinc shampoo gel

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

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Before using ketoconazole gel and pyrithione zinc shampoo gel:

Some medical conditions may interact with ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel. Because little, if any, of ketoconazole gel and pyrithione zinc shampoo gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel:

Use ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel. Spread a thick layer of ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel as directed by your doctor or the package labeling.

Ask your health care provider any questions you may have about how to use ketoconazole gel and pyrithione zinc shampoo gel.

Important safety information:

  • Ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel in your vagina.
  • Check with your doctor before you use ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel.
  • Ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel while you are pregnant. It is not known if ketoconazole gel and pyrithione zinc shampoo gel is found in breast milk after topical use. If you are or will be breast-feeding while you use ketoconazole gel and pyrithione zinc shampoo gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ketoconazole gel and pyrithione zinc shampoo 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. Ketoconazole gel and pyrithione zinc shampoo gel is harmful if swallowed.

Proper storage of ketoconazole gel and pyrithione zinc shampoo gel:

Store ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel out of the reach of children and away from pets.

General information:

  • If you have any questions about ketoconazole gel and pyrithione zinc shampoo gel, please talk with your doctor, pharmacist, or other health care provider.
  • Ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ketoconazole gel and pyrithione zinc shampoo 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 ketoconazole gel and pyrithione zinc shampoo gel.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.

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