Imiquimod topical (for the skin) is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Imiquimod topical also treats genital warts on the outside of the body, in adults and children at least 12 years old. imiquimod topical is not a cure for genital warts.

Imiquimod topical is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Imiquimod topical may also be used for purposes not listed in this medication guide.

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.

Imiquimod comes as a cream to apply to the skin.

If you are using imiquimod cream to treat actinic keratoses, you will probably apply it once a day for 2 days a week, 3 to 4 days apart (e.g., Monday and Thursday or Tuesday and Friday). Do not apply the cream to an area larger than your forehead or cheek (about 2 inches by 2 inches). Imiquimod cream should be left on the skin for approximately 8 hours. Continue using imiquimod cream for a full 16 weeks, even if all the actinic keratoses are gone, unless you are told otherwise by your doctor.

If you are using imiquimod cream to treat superficial basal cell carcinoma, you will probably apply it once a day for 5 days a week (e.g., Monday through Friday). Apply the cream to the basal cell carcinoma and the immediate surrounding area. Imiquimod cream should be left on the skin for approximately 8 hours. Continue using imiquimod for a full 6 weeks, even if the superficial basal cell carcinoma appears to be gone, unless you are told otherwise by your doctor.

If you are using imiquimod cream to treat genital and anal warts, you will probably apply it once a day for 3 days a week (e.g., Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). Imiquimod cream should be left on the skin for 6 to 10 hours. Continue using imiquimod until all of the warts are healed, up to a maximum of 16 weeks.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use imiquimod exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not cover the treated area with a tight bandage or dressing unless told to do so by your doctor. Cotton gauze dressings may be used if needed. Cotton underwear may be worn after treating the genital or anal areas.

If you are using imiquimod cream to treat genital or anal warts, you should avoid sexual (oral, anal, genital) contact while the cream is on your skin. Imiquimod cream may weaken condoms and vaginal diaphragms.

Uncircumcised men who are treating warts under the penis foreskin should pull the foreskin back and clean daily and before each treatment.

Imiquimod cream is only for use on the skin. Do not apply imiquimod cream in or near your eyes, lips, nostrils, vagina, or anus. If you get imiquimod cream in your mouth or eyes, rinse well with water right away.

Imiquimod cream comes in single-use packets. Dispose of any open packets if you do not use all of the cream.

To use the cream, follow these steps:

1. Wash your hands.
2. Wash the area to be treated with mild soap and water and allow it to dry.
3. Apply a thin layer of cream to the area to be treated, just before going to sleep.
4. Rub the cream into the skin until it disappears.
5. Wash your hands.
6. Leave the cream on the area for the amount of time your doctor has told you to do so. Do not bathe, shower, or swim during this time.
7. After the treatment time is over, wash the area with mild soap and water to remove any cream.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Using too much imiquimod topical or using it for too long can increase your risk of severe skin reactions. Do not use two different forms of imiquimod topical 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 imiquimod. 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 imiquimod topical will depend on the condition you are treating.

Actinic keratosis:

• Aldara is usually applied 2 times per week for 16 weeks.

• Zyclara is usually applied once daily for 2 weeks, followed by 2 weeks without treatment.

Genital warts:

• Aldara is usually applied 3 times per week for 16 weeks.

• Zyclara is usually applied once daily for up to 8 weeks.

Superficial basal cell carcinoma:

• Aldara is usually applied 5 times per week for 6 weeks. Apply the cream to the treatment area and surrounding skin, and rub in completely.

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

Imiquimod topical 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 with imiquimod topical.

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

Your doctor may tell you to stop using imiquimod topical 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 imiquimod topical (2 weeks for actinic keratitis, 8 weeks for genital warts).

Your doctor will need to check your skin on a regular basis. If you have superficial basal cell carcinoma, you may need a skin biopsy after you have completed your 5-week treatment with imiquimod topical.

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 imiquimod topical for genital warts on a child younger than 12 years old. All other uses of this medication are for adults over 18 only.

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. Imiquimod topical 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

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

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

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

Imiquimod 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 imiquimod 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: 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 imiquimod topical and call your doctor right away.

Imiquimod topical may cause serious side effects. 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)--skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.

Common side effects of imiquimod topical 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.

Keep all appointments with your doctor. If you are using imiquimod cream to treat superficial basal cell carcinoma, it is important to have regular follow-up visits with your doctor. Ask your doctor how often you should have your skin checked.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.