Scholl Verruca Removal System

1. Name Of The Medicinal Product

Scholl Verruca Removal System.

2. Qualitative And Quantitative Composition

Salicylic Acid Ph Eur 40% w/w.

3. Pharmaceutical Form

Plaster.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of common warts on the feet and hands.

4.2 Posology And Method Of Administration

Adults and children: Select a medicated disc from those supplied which best fits the size of the wart. Leave medicated disc in place on wart for 48 hours and repeat treatment. Continue treatment for up to twelve weeks if necessary. No distinction is made between age groups. Neonates: neonates should not be treated.

4.3 Contraindications

Not to be used by diabetics or those with severe circulatory disorders, except following a doctor's permission and recommendation. Not to be used if the skin around the wart is inflamed or broken. Not to be used on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.

4.4 Special Warnings And Precautions For Use

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not relevant to cutaneous use.

4.6 Pregnancy And Lactation

Safety during pregnancy and lactation has not been established.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Local irritation may occur.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: keratolytics. Mechanism of action: the mechanism of action of salicylic acid has not been established. Pharmacodynamic 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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

Salicylic acid has a low acute toxicity with oral LD₅₀ values of 480mg/kg in the mouse and 891mg/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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyvinyl Alkyl Ether (Low Molecular Weight); Polyvinyl Alkyl Ether (High Molecular Weight); Titanium Dioxide; Liquid Paraffin; 4,4-thio-bis-2-tert-butyl-5-methylphenol; Red Iron Oxide; Black Iron Oxide; Backing material; Twill Cloth; Polyethylene foam-coated plaster (closed cell).

6.2 Incompatibilities

Not relevant.

6.3 Shelf Life

Shelf life of the product as packed for sale: 3 years. Shelf life after first opening the container: 6 weeks.

6.4 Special Precautions For Storage

Store below 25^oC.

6.5 Nature And Contents Of Container

Sachet. Three separate sachets each containing fifteen medicated adhesive discs. Each set of fifteen discs comprised of three sizes of disc (3x5). Each pack contains fifteen cover plasters. These may be composed of an ecru coloured twill cloth for the standard product or tan coloured closed cell polyethylene foam coated plasters for the washproof variant. Both types of plaster are coated with a pressure sensitive adhesive.

6.6 Special Precautions For Disposal And Other Handling

Select a medicated disc from those supplied that best fits the size of the wart. Apply medicated disc to the wart with the fabric side uppermost. Cover medicated disc with one of the adhesive covering plasters supplied.

7. Marketing Authorisation Holder

Scholl Consumer Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 0587/0038.

9. Date Of First Authorisation/Renewal Of The Authorisation

27^th June 1994 / 29^th June 1999.

10. Date Of Revision Of The Text

August 2001.