Miconazole Nitrate, White Petrolatum Base, Zinc Oxide Topical ointment

What is this medicine?

MICONAZOLE; PETROLATUM; ZINC OXIDE (mi KON a zole; pe truh LEY tuhm; zingk OX ide) is an antifungal medicine. It is used to treat diaper rash complicated by a yeast infection. Do not use this medicine to prevent diaper rash.

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

What should I tell my health care provider before I take this medicine?

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

• immune system problems
• an unusual or allergic reaction to miconazole, petrolatum, zinc oxide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Apply this medicine with each diaper change. Gently cleanse the diaper area with mild soap and warm water. Pat the area dry with a soft towel. Apply a thin layer of medicine to the diaper area. Do not rub this medicine into the skin. Rubbing the skin can cause irritation. Finish the full course prescribed by your doctor or health care professional even if you think your condition is better. Do not stop using except on the advice of your doctor or health care professional.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children under 4 weeks old.

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 extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other skin products on the affected area without asking your doctor or health care professional.

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 medicine?

Tell your doctor if the diaper rash does not get better or if it gets worse. Do not use this medicine for longer than 7 days.

Do not use this medicine on any diaper rash that has not been tested for a yeast infection. Do not use this medicine on anyone for whom it was not prescribed.

Check the diaper often. Change the diaper at the first sign of wetness. Clean the diaper area with each diaper change. Even if you use this medicine, diaper rash will not go away if you do not keep the diaper area clean and dry.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• increased skin irritation
• worsening diaper rash

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.