Uses of Podofilox Gel:

• It is used to treat genital warts.
• It is used to treat perianal warts.

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

• If you have an allergy to podofilox or any other part of podofilox gel.
• If you are allergic to podofilox gel; any part of podofilox gel; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding or plan to breast-feed.

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 podofilox 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 Podofilox Gel?

• Tell all of your health care providers that you take podofilox gel. This includes your doctors, nurses, pharmacists, and dentists.
• Do not have any kind of sex when podofilox gel is on your genital or anal skin.
• Do not use podofilox gel for longer than you were told by your doctor.
• If your signs do not get better or if they get worse within 4 weeks, talk with your doctor.
• People using podofilox gel may get skin reactions where podofilox gel is used. These reactions may include burning or stinging, itching, pain, or redness. Call your doctor if you have skin reactions that are very bad, bother you, or do not go away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using podofilox gel while you are pregnant.

How is this medicine (Podofilox Gel) best taken?

Use podofilox gel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to take podofilox gel as you have been told by your doctor. Do not use more than you were told to use.
• Do not take podofilox gel by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• If you get podofilox gel in the eyes, flush right away with cool water and get medical help.
• Wash your hands before and after use.
• Put a thin layer on the affected skin.
• Put podofilox gel on as you have been told by the doctor or on the package labeling.
• Use only on the warts as you have been told by your doctor.
• Avoid putting on healthy skin.
• Let the treated skin dry before letting it touch untreated skin.
• This medicine may catch on fire. Do not use near an open flame or while smoking.

What do I do if I miss a dose?

• Put on 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 put on 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.
• Bleeding where podofilox gel is used.
• Swelling where podofilox gel is used.

What are some other side effects of Podofilox 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:

• Headache.

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 Podofilox Gel?

• Store at room temperature. Do not freeze.
• Protect from heat or open flame.
• Keep lid tightly closed.
• 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 podofilox 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.