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WARTEX OINTMENT

Active substance(s): SALICYLIC ACID

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Wartex Ointment

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic acid BP 50.00%

3

PHARMACEUTICAL FORM
Ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of hard and ragged warts.

4.2

Posology and method of administration
Topical. Apply a trace of ointment on to wart only for several days. Rub
surface gently with file or pumice stone once weekly. Repeat as necessary.

4.3

Contraindications
Hypersensitivity to topical salicylate or any of the ingredients in Wartex
ointment.

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 wart or surrounding skin is broken or inflamed.
Do not use on moles, birthmarks, unusual warts with hair growth, on facial
warts in the anal or perianal area or any other skin lesions for which Wartex is
not indicated.

4.4

Special warnings and precautions for use
Do not apply Wartex to soft warts or moist or tender parts of the body, avoid
contact with eyes and mucous membranes. If contact occurs flush with water
for 15 minutes. Avoid contact with normal skin around the Wart. 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 Wartex and other topical medicines should therefore be
avoided.

4.6

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

4.7

Effects on ability to drive and use machines
None stated.

4.8

Undesirable effects
A localised irritant reaction may occur if Wartex is applied to normal skin
surrounding the wart. This may be controlled by temporarily discontinuing the
use of Wartex and by being careful to apply it only to the wart 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 Wartex is used as indicated.

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 Wartex.

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 paraffin BP
Glycerol BP
Liquid paraffin BP

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 printed collapsible aluminium tube with membrane nozzle.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
OPTIMA CONSUMER HEALTH LIMITED
CONCEPT HOUSE

BRACKENBECK ROAD
BRADFORD
BD7 2LW

8

MARKETING AUTHORISATION NUMBER(S)
PL 40575/0011

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28 September 2004

10

DATE OF REVISION OF THE TEXT
25/07/2012

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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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