Zyclara is an immune response modifier.

Zyclara cream is a prescription medicine used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp of adults who are over 18 years of age.

Zyclara cream is also used to treat genital warts that appear on the outside of the body in adults and children who are at least 12 years old. This medicine is not a cure for genital warts.

Using too much Zyclara, or using it for too long can increase your risk of severe skin reactions. Follow your doctor's instructions.

Do not use Zyclara cream on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using this medicine.

Before using Zyclara cream, tell your doctor if you have a weak immune system, an autoimmune disorder, graft-versus-host disease, or if you have recently received a bone marrow transplant or cord blood transplant.

When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination. Avoid exposure to sunlight or tanning beds. Imiquimod can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Zyclara ceam 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 this medicine. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

Zyclara cream will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

If you are treating the genital or rectal area with Zyclara, avoid sexual activity while the medicine is on your skin. Zyclara can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm for birth control, these items could break if the rubber weakens and an unplanned pregnancy could result.

Use Zyclara exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take by mouth. Topical medicine is for use only on the skin.

Using too much Zyclara or using it for too long can increase your risk of severe skin reactions. Do not use two different forms of imiqtopical on the same treatment area.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after applying Zyclara. Also wash the skin to be treated and allow it to dry for at least 10 minutes before applying the medicine.

Apply the cream in a thin layer and rub in completely. Use at bedtime and leave the medicine on for 8 hours. In the morning, wash the skin with water and a mild soap. Do not cover treated skin with any type of plastic bandaging (you may use cotton gauze). Wear only cotton underwear when treating genital warts.

How often and how long you use Zyclara will depend on the condition you are treating.

Actinic keratosis:

• Apply once daily for 2 weeks, followed by 2 weeks without treatment.

Genital warts:

• Apply once daily for up to 8 weeks.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Zyclara is not a cure for genital warts. You may still spread this condition to others through vaginal, anal, or oral sex. You also may develop new lesions during treatment.

Call your doctor if the condition you are treating with Zyclara does not improve, or if it gets worse.

Your doctor may tell you to stop using Zyclara for several days if you have a skin reaction to this medicine. Even if you have skipped some of your doses, do not add time to the total number of weeks you use this medicine (2 weeks for actinic keratitis, 8 weeks for genital warts).

Store at room temperature. Do not freeze. Store the pump in an upright position. Keep each packet unopened until you are ready to use it.

Do not use Zyclara for genital warts on a child younger than 12 years old. All other uses of this medication are for adults over 18 only.

To make sure Zyclara is safe for you, tell your doctor if you have ever had:

• a weak immune system or autoimmune disorder;

• a sunburn or other skin problems; or

• graft-versus-host disease.

If you are treating the genital or rectal area, avoid sexual activity while the medicine is on your skin. Zyclara cream can weaken rubber condoms or diaphragms, which could break during sex and result in an unplanned pregnancy.

Tell your doctor if you are pregnant or breastfeeding.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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

Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.

Avoid swimming or taking a bath or shower while the medicine is on your skin.

Avoid using Zyclara on open wounds or on skin that has not yet healed from surgery or other medical treatment.

Avoid getting this medicine in your eyes, nose, mouth, vagina, or rectum. If contact does occur, rinse with water.

Avoid exposure to sunlight or tanning beds. Imiquimod can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Zyclara will not protect against sexually transmitted diseases, including genital warts, chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safer sex practices.

Do not use Zyclara to treat any condition that has not been checked by your doctor. Do not share this medicine with another person, even if they have the same symptoms you have.

Get emergency medical help if you have signs of an allergic reaction to Zyclara: hives; difficult 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 was applied.

When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using Zyclara and call your doctor right away.

Call your doctor at once if you have:

• flu-like symptoms such as fever, chills, nausea, tiredness, body aches, or swollen glands;

• bleeding or swelling where you applied this medicine; or

• symptoms of herpes zoster (shingles) - sores or blisters, itching, tingling, burning pain, rash on your face or torso.

Common Zyclara side effects may include:

• minor skin pain, irritation, itching, redness, dryness, flaking, scabbing, crusting, scaling, or swelling where the medicine was applied;

• changes in the color of treated skin (may be permanent);

• headache;

• tiredness; or

• nausea.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.