March 21, 2017

Sinecatechins Topical ointment

What is this medicine?

SINECATECHINS is made from green tea leaves. It is used to treat external genital or anal warts. This medicine is not a cure. New warts may appear during or after treatment.

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

  • open wounds in the area of treatment

  • warts in the vaginal or rectum

  • an unusual or allergic reaction to sinecatechins, 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. Follow the directions on the prescription label. Wash hands before and after use. Dab a thin layer of this medicine to each wart as directed. Do not use this medicine inside the vagina or the rectum. Women using tampons should insert the tampon before using this medicine. Do not bandage or tightly cover the treated area. Do not use this medicine for more than 16 weeks. Do not use more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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?

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?

Visit your doctor or health care professional for regular checks on your progress. If you get new warts within the 16 week treatment, treat the new warts with this medicine. Talk to your doctor if you have warts that do not go away or if you get new warts after 16 weeks.

Sexual (genital, oral, anal) contact should be avoided while the medication is on the skin. Wash the skin with mild soap and water before any sexual activity. This medicine may weaken condoms and vaginal diaphragms.

You may pass warts to another person even while you are taking this medicine. Talk to your doctor about how to stop the spread of infection.

This medicine can make the treated area more sensitive to the sun. Keep the affected area out of the sun. Do not use sun lamps or tanning beds/booths.

This medicine can stain lightly colored clothing or bedding.

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

  • blister or new sore where applied

  • burning or lasting pain

  • unusual bleeding or discharge

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • change in skin color or scarring

  • irritation, redness, sting, swelling at site where applied

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 in the refrigerator or up to 25 degrees C (77 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.


March 21, 2017


U.S. FDA-approved Package Insert