Podofilox prevents the growth of certain types of cells.

Podofilox topical (for the skin) is used to treat genital warts that appear on the outside of the body, but podofilox topical is not a cure for genital warts.

Podofilox topical may also be used for purposes not listed in this medication guide.

Do not use this medication on any warts or skin growths that have not been checked by your doctor.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your healthcare provider may show you how to apply this medicine at home.

Using more of this medicine will not make it work better, and may increase side effects.

This medicine is usually applied in the morning and evening for 3 days in a row, followed by 4 days of not using the medicine. This 7-day treatment cycle should be repeated up to 4 times, or until you can no longer see any signs of wart tissue.

Wash your hands before applying podofilox topical. Also wash the skin area to be treated, and allow it to dry completely before applying the medicine.

Apply podofilox topical using the cotton applicator provided or with your finger. Apply the medicine only to the wart tissue and avoid getting it on healthy skin. If the genital wart is in a skin fold, spread the skin apart and apply the medicine. Allow the treated skin to dry before releasing the skin fold.

Wash your hands again after applying podofilox topical.

Call your doctor if your symptoms do not improve after 4 treatment cycles.

Podofilox topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with podofilox topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

Store at room temperature away from moisture and heat. Do not freeze.

Podofilox topical gel is flammable. Do not use it near high heat or open flame, or while you are smoking.

Usual Adult Dose for Condylomata Acuminata:

Solution or gel: Apply topically twice daily for 3 consecutive days, then discontinue for 4 consecutive days.
Duration: The cycle may be repeated until there is no visible wart tissue or for a maximum of four cycles.

You should not use podofilox topical if you are allergic to it.

Do not use podofilox topical on any warts or skin growths that have not been checked by your doctor.

It is not known whether podofilox topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether podofilox topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Podofilox topical is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may result if you absorb podofilox topical through your skin by applying too much of it. Symptoms may include nausea, vomiting, diarrhea, fever, flu symptoms, sores in your mouth and throat, numbness or tingling in your hands or feet, confusion, trouble breathing, or seizure (convulsions).

Do not have sex on the days you apply podofilox topical.

Avoid getting this medicine in your eyes. If this does happen, rinse with water and call your doctor. Do not place the gel or solution in your rectum, vagina, or urethra. If it does get into any of these areas, rinse with water.

Avoid having unprotected sex. Podofilox is not a cure for genital warts, and it will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safe ways to prevent transmission of disease during sex.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied.

Common side effects of podofilox topical may include:

• mild skin irritation (pain, swelling, burning, redness, itching, tingling, blisters, crusting, dryness, peeling) where the medicine was applied;

• headache, dizziness;

• sleep problems (insomnia);

• unpleasant skin odor;

• vomiting; or

• pain during sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.