Scholl Verruca Removal System 40% w/w Medicated PlastersVerruca Removal System 40% w/w Medicated Plasters

For the full list of excipients, see section 6.1

Medicated Plaster

For the treatment of common warts on the feet and hands.Topical application to the skin

Adults and Children aged 16 years and over

For best results the feet should be washed and dried before use. Select a medicated disc from those supplied which best fits the size of the wart. Leave medicated disc in place on wart fro 48 hours and repeat treatment. Treatment should not continue for more than twelve weeks, except under medical advice.Should not be used in children under 16 years, except following a doctor's recommendation.

• Not to be used by diabetics or patients or patients with severe circulatory disorders or suffering from neuropathy, except following a doctor's prescription or recommendation.• Not to be used if the wart or surrounding skin is broken or inflamed.• Not to be used on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.• Not to be used in patients who are hypersensitive to salicylic acid (or other NSAIDs) or to any excipients in section 6.1• Not to be used by pregnant or breastfeeding patients (see section 4.6)

Discontinue use and remove plaster if excessive discomfort or irritation is experienced or if sensitivity develops.Do not apply to normal skin.For external use only.

Not relevant to cutaneous use

Pregnancy:

There is no data on the use of topical salicylic acid in pregnant women. Therefore the use of this product during pregnancy is contraindicated.

Breast feeding:

Salicylates should be given with caution to breast-feeding mothers because of the possible risk of Reye's syndrome in nursing infants and there is no data on the use of topical salicylic acid in breast feeding women. Therefore the use of this product during pregnancy is contraindicated.

Fertility:

There is no information on the effects of topical salicylic acid and fertility.

None stated

Local irritation or dermatitis may occur if applied to normal healthy skin surrounding the wart. This may be controlled by temporarily discontinuing use and by carefully applying only to the wart when the treatment is resumed.

Salicylic acid is readily absorbed through the skin, and symptoms of acute systemic salicylate poisoning have been reported after excessive use. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, and confusion, and may be controlled by reducing the dosage.

Keratolytics

Mechanism of Action

The mechanism of action of salicylic acid has not been established.

Pharmacodynamics Effects

Salicylates have analgesic, anti-inflammatory and antipyretic properties, much of which is ascribed to an inhibition of prostaglandin synthesis. However, the relevant pharmacodynamic effect of salicylic acid for this product is its “keratolytic” action. The mechanism of this effect has been investigated in animals and in man, and appears to be due to a reduction of intercellular cohesion and/or increasing endogenous hydration. The exact mechanism of action however has not yet been elucidated.

Salicylic acid can be absorbed following topical application. Plasma salicylate is largely protein-bound and is metabolised by oxidation and conjugation with some excreted unchanged. The elimination of salicylate follows first order kinetics with a half-life of about four hours except with high systemic doses which result in saturation of the elimination mechanism.

Salicylic acid has a low acute toxicity with oral LD₅₀ values of 480mg/kg in the mouse and 891 mg/kg in the rat. It is a dermal irritant but systemic toxicity from application of Scholl Verruca Removal System is extremely unlikely because of the small quantities applied.

Polyvinyl alkyl ether (Low Molecular Weight)Polyvinyl alkyl ether (High Molecular Weight)Titanium dioxideLiquid paraffin4, 4'-Thiobis (2-tert-butyl-5-mehtylphenol)Red iron oxideBlack iron oxideBacking materialTwill clothPolyethylene foam-coated plaster (closed cell)

Not relevant

3 years unopened.6 weeks after first opening.

Store below 25°C

Sachet

Any unused medicinal product or waste should be disposed of in accordance with local requirements.

Scholl Consumer Products Ltd103-105 Bath RoadSloughSL1 3UHUK

PL 00587 / 0038

27^th June 1994 / 26^th June 1999

22/03/2013