Uses of Ketoconazole Gel:

• It is used to control seborrheic dermatitis.

What do I need to tell my doctor BEFORE I take Ketoconazole Gel?

• If you are allergic to ketoconazole gel; any part of ketoconazole gel; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ketoconazole gel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ketoconazole Gel?

• Tell all of your health care providers that you take ketoconazole gel. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• This medicine may cause harm if swallowed. If ketoconazole gel is swallowed, call a doctor or poison control center right away.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• If you are breast-feeding, do not put ketoconazole gel right on the nipple or the area right around it.

How is this medicine (Ketoconazole Gel) best taken?

• Do not take ketoconazole gel by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Use as you have been told, even if your signs get better.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• If your skin is broken or swollen, talk with your doctor before using ketoconazole gel. Some drugs are not for use on broken or swollen skin.
• Do not bathe, shower, or swim for 3 hours after putting on.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Ketoconazole Gel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Irritation where ketoconazole gel is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ketoconazole Gel?

• Store at room temperature. Do not refrigerate or freeze.
• Store in a dry place. Do not store in a bathroom.
• Protect from heat or open flame.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ketoconazole gel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.