Uses of Sinecatechins:

• 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 Sinecatechins?

• If you are allergic to this medicine (sinecatechins); any part of this medicine (sinecatechins); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

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 this medicine (sinecatechins) 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 Sinecatechins?

• Tell all of your health care providers that you take this medicine (sinecatechins). This includes your doctors, nurses, pharmacists, and dentists.
• People using this medicine (sinecatechins) may get skin reactions where this medicine (sinecatechins) 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.
• This medicine will not cure your genital or perianal warts. You may get new warts while using this medicine (sinecatechins). Tell your doctor if you see any new warts.
• Make sure sores near the area to be treated are healed before using this medicine (sinecatechins).
• This medicine may stain clothing or fabric.
• Avoid sun, sunlamps, and tanning beds on the treated area.
• This medicine does not stop the spread of warts to others. Talk with your doctor about how to prevent the spread of genital warts to others.
• Do not have any kind of sex when this medicine (sinecatechins) is on your genital or anal skin.
• If you choose to have any kind of sex, use safe sex methods (condoms) until all warts are gone. You must wash off this medicine (sinecatechins) before having sex. Be sure the drug is washed off well. This medicine may weaken condoms and diaphragms. You may need an extra form of birth control while you are using this medicine (sinecatechins). Talk to your doctor about safe sex.
• If you use tampons, put the tampon in before using this medicine (sinecatechins). Do not get this medicine (sinecatechins) in the vagina when putting in a tampon.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Sinecatechins) best taken?

Use this medicine (sinecatechins) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not use longer than you have been told by the doctor.
• Do not take this medicine (sinecatechins) by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put in the vagina or anus.
• Do not put on open wounds.
• Wash your hands before and after use.
• You do not need to wash this medicine (sinecatechins) off the treated area before putting on the next dose. When the area is washed or you bathe, put this medicine (sinecatechins) on after you wash or bathe.
• Put a thin layer on the affected part.
• Avoid putting on healthy skin.
• Do not cover with dressings.
• If you are an uncircumcised man with warts under the foreskin, pull back the foreskin and clean every day.

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.
• Blisters or sores.
• Oozing or bleeding.
• Pain when passing urine.
• Trouble passing urine.
• Groin or pelvic pain or swelling.

What are some other side effects of Sinecatechins?

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 you have any side effects that bother you or do not go away.

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 Sinecatechins?

• Store at room temperature or in a refrigerator. Do not freeze.
• 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 this medicine (sinecatechins), 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.