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VERRUGON

Active substance(s): SALICYLIC ACID

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Verrugon

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid BP 50.00 % w/w.

3

PHARMACEUTICAL FORM
Ointment (off white greasy ointment)

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of verrucae (Plantar Warts).

4.2

Posology and method of administration
1.
Fix the self adhesive ring with the hole over the verruca.
2.
Squeeze a little Verrugon ointment into the hole and directly on to the
verruca.
3
Cover ring completely with plaster. Seal into position.
4.
Wash hands after use.
5.
Repeat treatment daily after gently pumicing or filing off the dead part
of the verruca.
To prevent transferring infection the emery board should only be used by the
patient and only for the verruca. Do not use to file nails.

4.3

Contraindications
Not to be used by patients with diabetes or those with severe circulatory
disorders or peripheral neuropathy except following a doctor s permission or
recommendation.
Do not use if the verruca is already infected or surrounding skin is broken or
inflamed.
Hypersensitivity to topical salicylate or any of the ingredients in Verrugon
Ointment.
Do not use on moles, birthmarks, hairy warts or any other skin lesions for
which Verrugon is not indicated.

4.4

Special warnings and precautions for use
Avoid contact with eyes or mucous membranes. If contact occurs flush with
water for 15 minutes. Avoid contact with normal skin around the Verruca.
Avoid using on areas of broken or damaged skin. Discontinue treatment if
excessive irritation occurs.
Remove immediately any surplus ointment from normal skin tissue.
Excessive prolonged use of topical salicylic acid may result in symptoms of
salicylism and therefore topical salicylic acid should not be used for prolonged
periods, in high concentrations, on large areas of the body.

4.5

Interaction with other medicinal products and other forms of interaction
There are no known interactions when used as indicated. However, salicylic
acid may increase the absorption of other topically applied medicines.
Concomitant use of Verrugon and other topical medicines should therefore be
avoided.

4.6

Pregnancy and lactation
Whilst there are no known contra-indications to the use Verrugon during
pregnancy and lactation, the safety has not been established. Verrugon should
therefore be used with caution or following professional advice.

4.7

Effects on ability to drive and use machines
Not applicable, none reported

4.8

Undesirable effects
A localised irritant reaction may occur if Verrugon is applied to normal skin
surrounding the Verruca. This may be controlled by temporarily discontinuing
the use of Verrugon and by being careful to apply it only to the Verruca when
treatment is resumed.

4.9

Overdose
Symptoms of acute systemic salicylate poisoning have been reported after the
application of salicylic acid to large areas of skin and for prolonged periods.
Symptoms include dizziness, tinnitus, deafness, sweating, nausea and
vomiting, headache and confusion. In children drowsiness and metabolic
acidosis commonly occur, hypoglycaemia may be severe.
Salicylism may also occur in the unlikely event of large quantities being
ingested. Salicylism is unlikely to occur if Verrugon is used as indicated.
Accidental oral ingestion should be treated immediately as recommended by
the National Poisons Information Service.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Salicylic Acid is a bacteriostatic and Fungicide. Used externally it has
keratolytic properties and produces slow and painless destruction of verrucae,
warts, corns and hard skin.

5.2

Pharmacokinetic properties
Salicylic acid may be percutaneously absorbed. However, there is no evidence
of any systemic absorption from the use of Verrugon.

5.3

Preclinical safety data
No other information relevant to the prescriber other than that already stated in
other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
White Soft Paraflin BP
Glycerin BP
Liquid Paraffin BP
Lanesta S (Wool Fat).

6.2

Incompatibilities
None stated.

6.3

Shelf life
60 months.

6.4

Special precautions for storage
Do not store above 25 C. Do not freeze.

6.5

Nature and contents of container
6g Collapsible aluminium tube with emery board 9 adhesive plasters and 9
corn rings.

6.6

Special precautions for disposal
1/ Fix the self adhesive ring with the hole over the verruca.
2/ Squeeze a little Verrugon ointment into the hole and directly on to the
verruca.
3/ Remove the backing paper from the plaster, cover ring completely with
plaster. Seal into position.
4/ Repeat daily after gently pumicing or filing off the dead part of the verruca.
5/ To prevent transferring infection the emery board should only be used by
the patient and only for the verruca. Do not use to file nails.

7

MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd
Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW,
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 40575/0010

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22 June 1983 / 8 January 1999

10

DATE OF REVISION OF THE TEXT
31/07/2012

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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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