Veregen is a herbal product made from green tea leaves.

Veregen ointment is used to treat genital and anal warts in adults. This medicine is for use only on warts outside the genitals and around the outside of the anus. It is not for use inside the vagina, cervix, rectum, or urethra (the tube for passing urine out of your bladder).

Veregen ointment will not cure genital or anal warts and you may develop new warts during or after treatment. Veregen will not keep you from spreading genital or anal warts to other people through sexual intercourse or skin-to-skin contact.

Before using Veregen ointment, tell your doctor if you have human papilloma virus (HPV),HIV or AIDS, or a weak immune system (from disease or medications such as steroids, chemotherapy, or radiation treatments).

Veregen will not cure genital or anal warts, and will not keep you from spreading the warts to other people through sexual intercourse or skin-to-skin contact. Veregen will not treat genital warts that are caused by the human papilloma virus (HPV).

Keep using the ointment until your warts have completely cleared. Do not use this medication for longer than 16 weeks without your doctors advice.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Veregen ointment is usually applied 3 times per day. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may perform a Pap smear or other medical tests to make sure Veregen is the right treatment for your condition.

Do not take this medicine by mouth. Veregen ointment is for use only on the skin. Do not use on open wounds.

Wash your hands before and after applying the ointment.

Apply only a small amount of ointment to each wart. Dab on the ointment, leaving a thin layer over each wart. Do not rub in completely.

Do not cover the warts with bandages, sanitary napkins, or other protective covering. Wear loose-fitting clothing over treated skin areas.

Do not wash off the ointment before applying your next dose. Reapply the ointment after you swim, bathe, or shower.

You should wash off the ointment before inserting a tampon into the vagina to avoid accidentally getting the medicine inside your vagina. Reapply the ointment after tampon insertion.

Men using the ointment on an uncircumcised penis should wash underneath the foreskin each day.

Keep using this medicine until your warts have completely cleared.

Do not use this medicine for longer than 16 weeks. Call your doctor if your warts do not clear up, or if they go away and then come back after treatment.

Veregen ointment can stain light-colored clothing or bed sheets. Avoid getting the ointment on these surfaces. Wear dark-colored clothing to prevent unwanted staining.

Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use.

You may also store the ointment in the refrigerator. Do not freeze.

Usual Adult Dose for Condylomata Acuminata:

Apply topically 3 times a day to affected area

You should not use Veregen if you are allergic to sinecatechins.

To make sure Veregen is safe for you, tell your doctor if you have:

• a weak immune system (caused by disease or by using certain medicine); or

• an allergy to green tea.

FDA pregnancy category C. It is not known whether Veregen 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 sinecatechins passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without medical advice.

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.

An overdose of Veregen ointment is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid getting this medicine in your eyes, nose, mouth, rectum, vagina, or urethra.

Avoid touching or allowing another person to touch the treated skin areas after you have applied the ointment.

Avoid exposing treated skin to sunlight or artificial UV rays (sunlamps or tanning beds).

Avoid using other medicine or skin products on the areas you treat with Veregen.

Avoid sexual intercourse while you have Veregen on your skin. Wash off the ointment before intercourse, even if you are using a condom. The ointment can weaken the latex in a rubber condom and it could break.

Using this medicine will not prevent you from passing genital or anal warts to another person during skin-to-skin contact or sexual intercourse. Talk with your doctor about safe ways to prevent transmission of genital warts during sex.

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

Wash off the ointment with mild soap and water and call your doctor at once if you have:

• severe redness or swelling of treated skin;

• severe burning, itching, or pain; or

• painful sores or blisters where the ointment was applied.

Common Veregen side effects may include:

• mild redness or burning of treated skin; or

• mild pain, itching, or discomfort.

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.