Tolnaftate; Hydrocortisone Gel or Topical Solution

What is this medication?

TOLNAFTATE; HYDROCORTISONE (tole NAF tate; hye droe KOR ti sone) treats fungal infections of the skin and nails. It may also be used to reduce pain, itching, swelling, or rashes caused by skin conditions. It works by decreasing inflammation and killing or preventing the growth of fungus on your skin. It is a combination of an antifungal and a topical steroid. It will not treat infections caused by bacteria or viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): DermacinRx Mycozyl HC

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Large areas of burned or damaged skin
• An unusual or allergic reaction to tolnaftate, hydrocortisone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. If you are treating your hands, only wash your hands before use. Do not use on healthy skin or over large areas of skin. Do not get this medication in your eyes. If you do, rinse it out with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed or for a longer time period than prescribed by your care team. Keep using it unless your care team tells you to stop.

Apply a thin film to the affected area and rub gently. Do not bandage or wrap the skin being treated unless directed to do so by your care team.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

If applying this medication to the diaper area of a child, do not cover with tight-fitting diapers or plastic pants. This may increase the amount of medication that passes through the skin and increase the risk of serious side effects.

People 65 years and older may be more likely to have damaged skin through aging, and this may increase side effects. This medication should only be used for brief periods and infrequently in older patients.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or take extra doses.

What may interact with this medication?

Interactions are not expected. Do not use any other skin products on the same area of skin without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning, itching, crusting, or peeling of treated skin
• Fragile or thinning skin that bruises easily

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in skin color
• Mild skin irritation, redness, or dryness
• Small, red, pus-filled bumps on skin around hair follicles
• Unexpected hair growth at application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 C (68 and 77 F). Do not freeze. Protect from light. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.