Fluorouracil, Diclofenac Sodium Topical cream
What is this medicine?
FLUOROURACIL; DICLOFENAC (flure oh YOOR a sil; dye KLOE fen ak) is a combination of a topical chemotherapy agent and non-steroidal anti-inflammatory drug (NSAID). It is used on the skin to treat skin cancer and skin conditions that could become cancer.
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:
DPD enzyme deficiency
high blood pressure
if you frequently drink alcohol containing drinks
open or infected skin
swelling or open sores at the treatment site
recent or planned coronary artery bypass graft (CABG) surgery
an unusual or allergic reaction to fluorouracil, diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is only for use on the skin. Follow the directions on the prescription label. Wash hands before and after use. Wash affected area and gently pat dry. To apply this medicine use a cotton-tipped applicator, or use gloves if applying with fingertips. If applied with unprotected fingertips, it is very important to wash your hands well after you apply this medicine. Avoid applying to the eyes, nose, or mouth. Apply enough medicine to cover the affected area. You can cover the area with a light gauze dressing, but do not use tight or air-tight dressings. Finish the full course prescribed by your doctor or health care professional, even if you think your condition is better. Do not stop taking except on the advice of your doctor or health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've 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, apply it as soon as you can. If it is almost time for your next dose, only use that dose. Do not apply extra doses. Contact your doctor or health care professional if you miss more than one dose.
What may interact with this medicine?
Interactions are not expected. Do not use any other skin products without telling 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 checks on your progress. You will need to use this medicine for 2 to 6 weeks. This may be longer depending on the condition being treated. You may not see full healing for another 1 to 2 months after you stop using the medicine.
Treated areas of skin can look unsightly during and for several weeks after treatment with this medicine.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
Where should I keep my
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
black or bloody stools, blood in the urine or vomit
difficulty breathing or wheezing
redness, blistering, peeling or loosening of the skin, including inside the mouth
severe redness and swelling of normal skin
slurred speech or weakness on one side of the body
trouble passing urine or change in the amount of urine
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
increased sensitivity of the skin to sun and ultraviolet light
pain and burning of the affected area
scaling or swelling of the affected area
skin rash, itching of the affected area
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 at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert