This medicine is an immune response modifier (IRM) used in adults with normal immune systems to treat certain types of precancerous skin lesions of the face or scalp known as actinic keratosis (AK) or to treat superficial basal cell carcinoma (sBCC) of the body, neck, arms, or legs. This medicine may also be used to treat external genital and perianal warts in patients 12 years of age and older or to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Your dosing schedule depends on your specific medical condition. If you are unsure how often to apply this medicine, contact your doctor, nurse, or pharmacist for instructions. This medicine is for use on the skin only. DO NOT APPLY THIS MEDICINE to any area of the body other than the treatment area. Do not apply it to open wounds, or to scraped, blistered, infected, or sunburned skin without first checking with your doctor. Wash and allow the area to completely dry (at least 10 minutes) before applying the medicine. Men who have not been circumcised and are treating warts under the foreskin should pull back the foreskin and clean the area just before treatment. Clean the area daily while you are using this medicine. Apply a thin layer of medicine to the affected area only. Gently rub the medicine in until it is evenly distributed. Wash your hands before and immediately after using this medicine. Do not apply this medicine inside the vagina or anus when applying the medicine to genital or perianal warts. DO NOT BANDAGE OR WRAP the affected area unless directed otherwise by your doctor. However, cotton underwear may be worn after applying medicine to the genital or anal area. After applying, discard any unused medicine left in the packet in a trash container, away from children and pets. Leave the medicine on the skin for the prescribed amount of time. Do not bathe or get the area wet until it is time to remove the medicine. The amount of time the medicine is left on the skin varies depending on what condition is being treated. Ask your doctor or pharmacist if you are unsure how long this medicine should be left on the skin. Wash the affected area with a mild soap and water when it is time to remove the medicine. STORE THIS MEDICINE at temperatures between 39 and 77 degrees F (4 and 25 degrees C) in the original container, away from heat, moisture, and light. DO NOT FREEZE. KEEP THIS MEDICINE out of the reach of children and pets. THROW AWAY ANY UNUSED MEDICINE that is left in the packet after the first use. Do not store this medicine in a packet for use at a later time. Throw away unused medicine in a trash container, away from children and pets. CONTINUE TO USE THIS MEDICINE as directed even if your condition improves. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, use it as soon as possible. If it is almost time for the next dose, skip the missed dose. DO NOT use 2 doses at once.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are using other topical medicines. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a weakened immune system; HIV infection; an autoimmune disorder (eg, rheumatoid arthritis, lupus); human papilloma virus (HPV) infection; other types of skin cancer; broken, damaged, or inflamed skin at the application site; rash at the application site; warts in the areas of your body other than the genital or anal areas; allergies; pregnancy; or breast-feeding. Tell your doctor if your skin has not completely healed from surgery or other types of treatment. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while using this medicine include burning, dryness, flaking, itching, redness, blisters or sores, thick or hardened skin, scabbing, drainage, changes in skin color, or peeling where the medicine is applied; swelling of surrounding areas; headache; back pain; tiredness; or diarrhea. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; fever, chills, or sore throat; flu-like symptoms (eg, tiredness, nausea, fever, chills, muscle or joint pain); oozing, blistering, or bleeding at the application site; severe irritation, sores, or ulcers at the application site; swollen lymph glands; trouble urinating; vaginal pain or swelling. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed. Symptoms of overdose may include severe flaking, cracking, or swelling of affected area; fainting; weakness; and dizziness.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.