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).
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.
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.
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 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.
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 1-800-222-1222. Canada residents can call
1-844-764-7669.
Do not share this medication with others.
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.
Store at room temperature away from heat and open flame.
This product is flammable. Do not refrigerate or freeze. Do not use if
there are crystals in the solution. Once the bottle is opened, this
medication expires after 3 months. 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.