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DIOMED WART GEL

Active substance(s): LACTIC ACID / SALICYLIC ACID

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Transcript
Diomed Wart PIL_WD18T-2:Layout 1

13/11/08

12:14

Page 1

PACKAGE LEAFLET Information for the user

12.0% w/w salicylic acid, 4.0% w/w lactic acid, gel
Please read all of this leaflet carefully before you start using this product.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
In this leaflet:
1. What Diomed Wart Gel is and what it
is used for
2. Before you use Diomed Wart Gel
3. How to use Diomed Wart Gel
4. Possible side effects
5. How to store Diomed Wart Gel
6. Further information

1. WHAT DIOMED WART GEL IS AND
WHAT IT IS USED FOR
• Diomed Wart Gel is a treatment for warts,
verrucas, corns and calluses.
– Warts and verrucas are small excessive
growths of skin caused by a type of virus.
Warts often occur on the fingers, or on the
back of the hands. You can recognise the
common wart by the rough “cauliflowerlike” appearance of the surface. Verrucas
occur only on the sole of the foot. They can
be painful, and often look like a small white
ring of skin with a black dot in the centre.
The virus is very infectious. This means that
warts and verrucas can grow and spread,
particularly if left untreated. The virus
can also be transferred from one person
to another.
– Corns and calluses are hard, thick pads
of skin caused by pressure and friction.
They usually occur on the feet due to
poorly fitting shoes. They can also occur
on the hands.
• Diomed Wart Gel is suitable for use by adults,
children and the elderly.
• The active ingredients in this product are
salicylic acid and lactic acid.
• The active ingredients work by:
– softening the hard skin growth, making it
easier to remove with a pumice stone or
emery board;
– they also help kill the virus that causes
warts and verrucas.

– take care not to apply the gel to
surrounding healthy skin, especially on
young children’s delicate skin, because
this may cause irritation;
– do not apply excessive amounts of gel.
• Keep the gel away from your eyes, nose,
and mouth, and from broken skin, cuts and
grazes.
• Avoid spillage as this may cause damage to
you, your clothing and your possessions (see
Section 4):
– do not fold the tube because this may
damage it and make it leak.
• The product is volatile and highly flammable.
Do not use it near flames or ignition sources
(eg burning cigarettes or anything else that
might ignite it).
• Avoid inhaling the vapour from the gel.
Using other medicines
This product is not known to affect, or to be
affected by any other medicines.
Pregnancy and breast feeding
This product can be used during pregnancy
and while breast feeding. The ingredients have
been in widespread use in this and similar
preparations for many years, without reports
of problems. However, safety trials have not
been conducted.
Driving and using machinery
Using this product is not known to affect your
ability to drive or use machinery.

3. HOW TO USE DIOMED WART GEL
Use it only on warts, verrucas, corns and
calluses on sites for which it is recommended.
Before you use this tube of gel for the first
time, open it as follows:
• Find a suitable surface, in case of accidental
spillage.
• Hold the tube upright, with the cap uppermost
and the base resting on a suitable surface.

Do not use Diomed Wart Gel if you are allergic
(hypersensitive) to salicylic acid, lactic acid or
any of the other ingredients of Diomed Wart Gel
listed in Section 6.
• Do not use the gel anywhere on or near
your face, armpits, breasts, bottom or genital
(sex) area.
• Do not use the gel on birthmarks, moles,
warts with hairs growing from them, or any
other spots.
• Do not use the gel if you are diabetic or
suffer from poor blood circulation to your
hands or feet.
Take special care when using this product:
• If you are unsure whether you have a wart,
verruca, corn or callus that is suitable for
treatment with Diomed, ask your doctor or
pharmacist before starting treatment.
• Apply the gel carefully, to the wart, verruca,
corn or callus only, by squeezing the tube
very gently:

• Unscrew and remove the combined white
nozzle/cap assembly from the tube.
• Remove the red collar and throw it away.
• Keep the tube upright for 30 seconds.
• Then, without squeezing or over-gripping the
tube, and with it still held upright and away
from your face:
– replace the white nozzle/cap assembly
onto the screw thread of the tube (taking
care to avoid “cross-threading”);
– tighten the nozzle/cap assembly firmly to
pierce the top of the tube;
– briefly loosen the cap (to release any slight
pressure in the tube) and then retighten.
• Please note that once in place, a small
gap will remain between the base of the
nozzle/cap and the top of the tube.
continued…

Prints: Pantone 279C & Pantone 485C

WD18T-2

2. BEFORE YOU USE DIOMED
WART GEL

Flat size: 160mm x 310mm

13/11/08

12:14

To use the gel (adults, children and the elderly):
Follow these steps once every day, usually in
the evening. Carry on using the gel in this way
until the wart, verruca, corn or callus disappears:
A. Soak the affected area in warm water for 2 to
3 minutes.
B. Dry the area thoroughly, using your own towel
if you have a wart or verruca (this will help
stop the infection spreading to other people).
C. Taking care to avoid squeezing the tube,
remove the protective cap, leaving the nozzle
attached to the tube.

D. Carefully apply a thin coating (one or two
drops) of the gel to the top of the wart,
verruca, corn or callus only:
– avoid the gel spreading to the surrounding
healthy skin;
– allow the gel to dry for a few minutes to
form a small white patch that sticks to the
treated area and is water resistant;
– there is no need to cover the treated area
with a sticking plaster;
– always replace the protective cap after use.
E. The next evening, carefully peel or pick off
the white patch of dried gel from the wart,
verruca, corn or callus:
– apply fresh gel as described above;
– if removal of the white patch is difficult,
carefully re-apply the gel directly over it and
leave it to dry. This will thicken the white
patch and make it easier to remove.
F. Once every week, before applying fresh
gel, gently rub the wart, verruca, corn or
callus with the emery board provided, or a
pumice stone:
– if you are treating a wart or verruca, do
not let anyone else use the emery board
or pumice stone as the infection may
spread to them.
G. The length of treatment will vary depending on
the size and resistance of the wart, verruca,
corn or callus:
– some may go in a relatively short time;
– some warts and verrucas can require up to
12 weeks treatment before they disappear;
– it is important that you do not give up on
the treatment until the wart, verruca, corn
or callus has disappeared (unless irritation
occurs, see section 4 below);
– if the wart, verruca, corn or callus has
not disappeared after twelve weeks of
treatment ask your doctor or pharmacist
for advice.
H. At the end of treatment, if the white patch is
difficult to remove, you can leave it because
it will eventually fall off by itself.
If the gel accidentally gets onto normal skin,
wipe it off straight away with a tissue, and, if
necessary, wash the area.
If the gel accidentally gets into the eyes or
mouth, it may cause damage. Rinse the eyes
or mouth with plenty of water. If rinsing one eye,
take care to avoid washing product into the other
eye. Then seek urgent hospital attention.
If you inhale a lot of the vapour from the gel
it may make you feel light-headed. If this
happens, get plenty of fresh air.
If you forget to use Diomed Wart Gel
Do not worry if you occasionally forget to use

Page 2

this product, just carry on using it when you
remember.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Diomed Wart Gel can cause
side effects although not everybody gets them:
• While the gel is working you may feel a slight
tingling sensation and / or some mild
tenderness at the treated area. This is usually
temporary, and in rare cases may appear as a
temporary blemish on the skin.
• If you mistakenly allow the gel to spread onto
and remain in contact with areas of normal
skin (see precautions in section 2), it may
cause irritation.
• If you spill the product on your clothes,
fabrics, jewellery or metal and polished
surfaces it may damage them permanently.
• Stop using this product and tell your doctor
or pharmacist if:
– you experience unacceptable discomfort or
if irritation persists, or;
– any of the side effects get serious, or you
notice any other side effects not mentioned
in this leaflet.

5. HOW TO STORE DIOMED WART GEL
• Keep out of the reach and sight of children.
• Do not use Diomed Wart Gel after the expiry
date shown on the fold of the tube and on the
carton. The expiry date refers to the last day
of that month.
• Do not store above 25°C.
• Always replace the cap tightly after use.
• The product is highly flammable. Keep it away
from flames or ignition sources.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION ABOUT
DIOMED WART GEL
What Diomed Wart Gel contains:
The active ingredients are salicylic acid (12.0%
w/w) and lactic acid (4.0% w/w).
The other ingredients are camphor, pyroxylin,
ethanol and ethyl acetate.
What Diomed Wart Gel looks like and
contents of the pack
The product is a clear colourless gel.
The product is available in a tube containing
8 g of gel. The tube has a special applicator
nozzle. Each pack also includes an emery board.
The Marketing Authorisation holder is Diomed
Developments Ltd, Tatmore Place, Gosmore,
Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is Aeropak, Viking Road,
Great Yarmouth, Norfolk, NR31 0NU, UK.
The Agent in Ireland is Cahill May Roberts,
Pharmapak, Chapelizod, Dublin 20.
This Leaflet was last approved in November
2008.
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following
information: Diomed, PL 00173/0401.
This is a service provided by the Royal National
Institute of Blind People (RNIB).

Prints: Pantone 279C & Pantone 485C

WD18T-2

Diomed Wart PIL_WD18T-2:Layout 1

Flat size: 160mm x 310mm

Diomed Wart PIL_WD19T-2:Layout 1

13/11/08

12:14

Page 1

PACKAGE LEAFLET Information for the user

12.0% w/w salicylic acid, 4.0% w/w lactic acid, gel
Please read all of this leaflet carefully before you start using this product.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
In this leaflet:
1. What Diomed Wart Gel is and what it
is used for
2. Before you use Diomed Wart Gel
3. How to use Diomed Wart Gel
4. Possible side effects
5. How to store Diomed Wart Gel
6. Further information

1. WHAT DIOMED WART GEL IS AND
WHAT IT IS USED FOR
• Diomed Wart Gel is a treatment for warts,
verrucas, corns and calluses.
– Warts and verrucas are small excessive
growths of skin caused by a type of virus.
Warts often occur on the fingers, or on the
back of the hands. You can recognise the
common wart by the rough “cauliflowerlike” appearance of the surface. Verrucas
occur only on the sole of the foot. They can
be painful, and often look like a small white
ring of skin with a black dot in the centre.
The virus is very infectious. This means that
warts and verrucas can grow and spread,
particularly if left untreated. The virus
can also be transferred from one person
to another.
– Corns and calluses are hard, thick pads
of skin caused by pressure and friction.
They usually occur on the feet due to
poorly fitting shoes. They can also occur
on the hands.
• Diomed Wart Gel is suitable for use by adults,
children and the elderly.
• The active ingredients in this product are
salicylic acid and lactic acid.
• The active ingredients work by:
– softening the hard skin growth, making it
easier to remove with a pumice stone or
emery board;
– they also help kill the virus that causes
warts and verrucas.

– take care not to apply the gel to
surrounding healthy skin, especially on
young children’s delicate skin, because
this may cause irritation;
– do not apply excessive amounts of gel.
• Keep the gel away from your eyes, nose,
and mouth, and from broken skin, cuts and
grazes.
• Avoid spillage as this may cause damage to
you, your clothing and your possessions (see
Section 4):
– do not fold the tube because this may
damage it and make it leak.
• The product is volatile and highly flammable.
Do not use it near flames or ignition sources
(eg burning cigarettes or anything else that
might ignite it).
• Avoid inhaling the vapour from the gel.
Using other medicines
This product is not known to affect, or to be
affected by any other medicines.
Pregnancy and breast feeding
This product can be used during pregnancy
and while breast feeding. The ingredients have
been in widespread use in this and similar
preparations for many years, without reports
of problems. However, safety trials have not
been conducted.
Driving and using machinery
Using this product is not known to affect your
ability to drive or use machinery.

3. HOW TO USE DIOMED WART GEL
Use it only on warts, verrucas, corns and
calluses on sites for which it is recommended.
Before you use this tube of gel for the first
time, open it as follows:
• Find a suitable surface, in case of accidental
spillage.
• Hold the tube upright, with the cap uppermost
and the base resting on a suitable surface.

Do not use Diomed Wart Gel if you are allergic
(hypersensitive) to salicylic acid, lactic acid or
any of the other ingredients of Diomed Wart Gel
listed in Section 6.
• Do not use the gel anywhere on or near
your face, armpits, breasts, bottom or genital
(sex) area.
• Do not use the gel on birthmarks, moles,
warts with hairs growing from them, or any
other spots.
• Do not use the gel if you are diabetic or
suffer from poor blood circulation to your
hands or feet.
Take special care when using this product:
• If you are unsure whether you have a wart,
verruca, corn or callus that is suitable for
treatment with Diomed, ask your doctor or
pharmacist before starting treatment.
• Apply the gel carefully, to the wart, verruca,
corn or callus only, by squeezing the tube
very gently:

• Unscrew and remove the combined white
nozzle/cap assembly from the tube.
• Remove the red collar and throw it away.
• Keep the tube upright for 30 seconds.
• Then, without squeezing or over-gripping the
tube, and with it still held upright and away
from your face:
– replace the white nozzle/cap assembly
onto the screw thread of the tube (taking
care to avoid “cross-threading”);
– tighten the nozzle/cap assembly firmly to
pierce the top of the tube;
– briefly loosen the cap (to release any slight
pressure in the tube) and then retighten.
• Please note that once in place, a small
gap will remain between the base of the
nozzle/cap and the top of the tube.
continued…
Prints: Pantone 469

WD19T-2

2. BEFORE YOU USE DIOMED
WART GEL

Flat size: 160mm x 310mm

13/11/08

12:14

To use the gel (adults, children and the elderly):
Follow these steps once every day, usually in
the evening. Carry on using the gel in this way
until the wart, verruca, corn or callus disappears:
A. Soak the affected area in warm water for 2 to
3 minutes.
B. Dry the area thoroughly, using your own towel
if you have a wart or verruca (this will help
stop the infection spreading to other people).
C. Taking care to avoid squeezing the tube,
remove the protective cap, leaving the nozzle
attached to the tube.

D. Carefully apply a thin coating (one or two
drops) of the gel to the top of the wart,
verruca, corn or callus only:
– avoid the gel spreading to the surrounding
healthy skin;
– allow the gel to dry for a few minutes to
form a small white patch that sticks to the
treated area and is water resistant;
– there is no need to cover the treated area
with a sticking plaster;
– always replace the protective cap after use.
E. The next evening, carefully peel or pick off
the white patch of dried gel from the wart,
verruca, corn or callus:
– apply fresh gel as described above;
– if removal of the white patch is difficult,
carefully re-apply the gel directly over it and
leave it to dry. This will thicken the white
patch and make it easier to remove.
F. Once every week, before applying fresh
gel, gently rub the wart, verruca, corn or
callus with the emery board provided, or a
pumice stone:
– if you are treating a wart or verruca, do
not let anyone else use the emery board
or pumice stone as the infection may
spread to them.
G. The length of treatment will vary depending on
the size and resistance of the wart, verruca,
corn or callus:
– some may go in a relatively short time;
– some warts and verrucas can require up to
12 weeks treatment before they disappear;
– it is important that you do not give up on
the treatment until the wart, verruca, corn
or callus has disappeared (unless irritation
occurs, see section 4 below);
– if the wart, verruca, corn or callus has
not disappeared after twelve weeks of
treatment ask your doctor or pharmacist
for advice.
H. At the end of treatment, if the white patch is
difficult to remove, you can leave it because
it will eventually fall off by itself.
If the gel accidentally gets onto normal skin,
wipe it off straight away with a tissue, and, if
necessary, wash the area.
If the gel accidentally gets into the eyes or
mouth, it may cause damage. Rinse the eyes
or mouth with plenty of water. If rinsing one eye,
take care to avoid washing product into the other
eye. Then seek urgent hospital attention.
If you inhale a lot of the vapour from the gel
it may make you feel light-headed. If this
happens, get plenty of fresh air.
If you forget to use Diomed Wart Gel
Do not worry if you occasionally forget to use

Page 2

this product, just carry on using it when you
remember.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Diomed Wart Gel can cause
side effects although not everybody gets them:
• While the gel is working you may feel a slight
tingling sensation and / or some mild
tenderness at the treated area. This is usually
temporary, and in rare cases may appear as a
temporary blemish on the skin.
• If you mistakenly allow the gel to spread onto
and remain in contact with areas of normal
skin (see precautions in section 2), it may
cause irritation.
• If you spill the product on your clothes,
fabrics, jewellery or metal and polished
surfaces it may damage them permanently.
• Stop using this product and tell your doctor
or pharmacist if:
– you experience unacceptable discomfort or
if irritation persists, or;
– any of the side effects get serious, or you
notice any other side effects not mentioned
in this leaflet.

5. HOW TO STORE DIOMED WART GEL
• Keep out of the reach and sight of children.
• Do not use Diomed Wart Gel after the expiry
date shown on the fold of the tube and on the
carton. The expiry date refers to the last day
of that month.
• Do not store above 25°C.
• Always replace the cap tightly after use.
• The product is highly flammable. Keep it away
from flames or ignition sources.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION ABOUT
DIOMED WART GEL
What Diomed Wart Gel contains:
The active ingredients are salicylic acid (12.0%
w/w) and lactic acid (4.0% w/w).
The other ingredients are camphor, pyroxylin,
ethanol and ethyl acetate.
What Diomed Wart Gel looks like and
contents of the pack
The product is a clear colourless gel.
The product is available in a tube containing
8 g of gel. The tube has a special applicator
nozzle. Each pack also includes an emery board.
The Marketing Authorisation holder is Diomed
Developments Ltd, Tatmore Place, Gosmore,
Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is Pharmasol Ltd, North Way,
Walworth Industrial Estate, Andover, Hampshire,
SP10 5AZ, UK.
The Agent in Ireland is Cahill May Roberts,
Pharmapak, Chapelizod, Dublin 20.
This Leaflet was last approved in November
2008.
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following
information: Diomed, PL 00173/0401.
This is a service provided by the Royal National
Institute of Blind People (RNIB).

Prints: Pantone 469

WD19T-2

Diomed Wart PIL_WD19T-2:Layout 1

Flat size: 160mm x 310mm

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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