Scholl Seal and Heal Verruca Removal Gel

1. Name Of The Medicinal Product

Scholl Seal and Heal Verruca Removal Gel.

2. Qualitative And Quantitative Composition

Salicylic Acid EP 12.5% w/w; Camphor BP 3.11% w/w.

3. Pharmaceutical Form

Topical solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of corns, callouses, common warts and plantar warts (verrucas).

4.2 Posology And Method Of Administration

Adults and children over 12 years: For best results the feet should be washed and dried before use. The product should be applied directly to the wart, verruca, callous or corn twice a day, until the wart, verruca, callous or corn has been removed. Treatment may be continued for up to twelve weeks except on medical advice. No distinction is made between different categories of patient. Children: Not recommended for children under twelve, except following a doctor's recommendation.

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 by those sensitive to salicylic acid or any of the other constituents of the product. Not to be used if the corn, callous, wart, verruca or surrounding skin is broken or inflamed. When indicated for the treatment of warts and verrucae, the product must not be used on moles, birthmarks, hairy or genital warts. It must not be used on the face or anogenital skin or mucosa.

4.4 Special Warnings And Precautions For Use

Discontinue use and remove any dressing if excessive discomfort is experienced. If the product comes into contact with normal skin, wash off immediately with copious water. 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 for use in pregnancy and during lactation has not been established.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Local irritation or dermatitis may occur.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC classification is D11F A. The overall action of Scholl Seal and Heal Verruca Removal Gel is that of a keratolytic, due to the presence of salicylic acid. Camphor provides an additional effect of mild analgesia due to its counter irritant properties. 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 lipid modifying effect in the lipid bilayers of the skin rather than a keratolytic action. It is thought that the salicylic acid increases lipid structure fluidity so allowing moisture to penetrate into the areas surrounding the corn, callous, wart or verruca. This in turn leads to a pressure build up causing the corn, callous, wart or verruca to be pushed upwards. Camphor has a number of actions including, respiratory stimulation, expectorant and calmative properties. However, the relevant pharmacodynamic action of camphor in this product is its counter-irritant property.

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 results in saturation of the elimination mechanism. Camphor is readily absorbed from all administration sites. Once absorbed, it is hydroxylated in the liver to yield hydroxy-camphor metabolites, which are then conjugated with glucoronic acid and excreted in the urine.

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 12.5% w/w salicylic acid is extremely unlikely because of the small quantities applied. Camphor has a high toxicity with a probable human lethal dose from 50 mg/kg to 500 mg/kg, intraperitoneal LD₅₀ of 3000 mg/kg has been reported in mice. Ingestion of camphor can lead to nausea, vomiting, mental confusion, delirium, clonic convulsions, coma, respiratory failure, and death in humans. Relevant safety data, however, relates to the topical use of camphor in adults. Camphor is a known irritant, with cases of non-immunological contact urticaria being reported following cutaneous use. The dose presented in Scholl Seal and Heal Verruca Removal Gel is 2.8% w/v giving a total of 0.28mg in 10ml of finished product. At this dosage, it is unlikely that toxicity will occur.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pyroxylin BP; Caster Oil BP; Methoxyisopropanol; Acetone BP.

6.2 Incompatibilities

Not relevant.

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Store at or below 25C.

Keep out of reach of children.

6.5 Nature And Contents Of Container

Container: Annealed aluminium tube with internal lacquer, fitted with a tamper evident HDPE cap, with cardboard outer carton. Contents: Each tube contains 5ml.

6.6 Special Precautions For Disposal And Other Handling

No special precautions.

7. Marketing Authorisation Holder

Scholl Consumer Products Ltd, Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 0587/5003R.

9. Date Of First Authorisation/Renewal Of The Authorisation

31^st September 1990 / 23^rd May 2003

10. Date Of Revision Of The Text

June 2006.