Uses

This medication is used to treat certain skin growths on the face, forehead, or balding scalp of adults. These skin growths are caused by too much sun exposure, and if not treated, may turn into skin cancer. Fluorouracil is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. Salicylic acid works by softening the top layer of skin which helps fluorouracil work better. Salicylic acid belongs to the same class of drugs as aspirin (salicylates).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Using the brush applicator provided, apply a thin film of this medication as directed by your doctor on the clean, dry skin growth, usually once daily. Let the solution dry to form a film layer. Do not remove this film layer until it is time for the next application. Do not cover the area with a dressing. Wash your hands before and after using this medication.

Use this medication until the skin growth has completely cleared or for up to 12 weeks as directed. You may see improvement as early as 6 weeks after starting treatment, but it may take up to 8 weeks after stopping treatment to see complete healing.

Do not get this medication in your eyes, nose, mouth, or on your genitals. If you do get the medication in these areas, rinse with plenty of water.

Avoid getting this medication on your clothes, on fabrics, or on acrylic bathtubs since it may permanently stain them.

This medication may cause serious harm (even death) in pets. Keep this medication securely away from pets, and do not allow pets to lick the area where the medication was applied. Contact your vet right away if your pet comes into contact with this medication.

Do not apply more of this medication or use it more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Skin irritation, burning, redness, peeling, pain, swelling, or changes in skin color near the treated area may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Your doctor may direct you to use this medication less often if you have side effects.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• ringing in the ears
• fast breathing
• fast heartbeat
• confusion
• unusual tiredness

Stop using this medication, wash the treated area with warm water, and get medical help right away if you have any very serious side effects, including:

• nausea
• vomiting
• diarrhea
• mouth sores
• stomach/abdominal pain
• black/bloody stools
• vomit that looks like coffee grounds
• signs of infection (such as fever, chills, sore throat that doesn't go away)
• easy bruising/bleeding

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to fluorouracil or salicylic acid; or to flucytosine, capecitabine, or other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain enzyme deficiency (dihydropyrimidine dehydrogenase - DPD)
• kidney disease
• problems sensing touch/pain/temperature on your skin (such as nerve damage caused by diabetes)

This medication makes the treated skin area more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

This product is flammable. Store at room temperature away from heat and open flame. Do not refrigerate or freeze. Keep the bottle tightly closed to prevent the solution from drying up. Do not use if there are crystals in the solution. Discard this product 3 months after opening. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.