When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to sinecatechins, or or other components of this product.

How to Use This Medicine:
Ointment

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is for use on the skin only. Do not get it inside your eyes, nose, mouth, vagina, or anus. Do not use on open wounds or on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
• Women using tampons should insert the tampon first before applying the ointment. If the tampon needs to be changed while the ointment is on the skin, avoid getting the ointment into the vagina.
• Men who are not circumcised and treating genital warts under the foreskin should draw back the foreskin and clean the area daily.
• Wash your hands with soap and water before and after you use this medicine.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Do not wash off the ointment from the treated area before you apply the next dose. When you wash the treatment area or bathe, apply the ointment afterwards.
• Do not cover the treated area with a bandage unless directed by your doctor. You may wear loose-fitting underwear after applying this medicine.
• Keep using this medicine until all the warts have cleared up. However, you should not use this medicine for longer than 16 weeks.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a weakened immune system.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the ointment off your skin before you engage in any sexual activity. Also, the medicine contains oils that can weaken latex (rubber) condoms, or diaphragms causing them not to work properly.
• This medicine will not keep you from spreading genital warts to other people. Talk with your doctor about safe sex practices.
• This medicine is not a cure for genital or anal warts. You may still develop new warts during or after your treatment.
• Sinecatechins may make your skin more sensitive to sunlight. Do not expose the area being treated with this medicine to sunlight, sunlamps, or tanning beds.
• This medicine may stain your clothes and bedding.
• Many patients experience redness, swelling, sores or blisters, burning, or itching after using this medicine. If you experience a severe skin reaction, remove the ointment by washing the area with mild soap and water and contact your doctor right away.
• Call your doctor if your symptoms do not improve or if they get worse.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding, discharge, or skin sores or ulcers.
• Blistering, flaking, peeling, or red skin rash.
• Difficult or painful urination.
• Severe burning, pain, swelling, redness, or irritation on treated skin areas.
• Swollen, painful, or tender lymph glands in groin.

If you notice these less serious side effects, talk with your doctor:

• Mild skin rash, itching, or irritation.
• Tight foreskin of the penis.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088