Scholl Corn and Callous Removal Liquid

Scholl Medicated Corn and Callous Removal Liquid

Seal and Heal Verruca Removal Gel

Boots Verruca Removal Gel

Topical solution

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

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.

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 verruca, 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.

Discontinue use and remove any dressing if excessive discomfort is experienced.

If the liquid comes into contact with normal skin wash off immediately with copious water.

Do not apply to normal skin.

For external use only.

Not relevant to cutaneous use.

Safety for use in pregnancy and during lactation has not been established.

None stated.

Local irritation or dermatitis may occur.

None stated.

ATC classification is D11F A.

The overall action of Corn and Callous Removal Liquid is that of 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 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. This in turn leads to a pressure build up causing the corn 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.

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.

Camphor is readily absorbed from all administration sites. Once absorbed it is hydrodylated in the liver to yield hydroxy-camphor metabolites, which are then conjugated with glucuronic acid and excreted in the urine.

Salicylic Acid has a low acute toxicity with oral LD₅₀ values of 480 mg/kg in the mouse and 891 mg/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 50mg/kg to 500 mg/kg. Intraperitoneal LD₅₀ of 3000mg/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 Corn and Callous Removal Liquid is 2.8% W/V giving a total of 0.28mg in 10ml of the finished product. At this dosage it is unlikely that toxicity will occur.

Pyroxylin BP

Castor Oil BP

Methoxyisopropanol

Acetone BP

Not relevant.

5 years.

Store at or below 25ºC

Keep out of the reach of children.

Container: Glass bottle fitted with a polypropylene tamper evident cap and applicator

Contents: Each bottle contains 10 ml

Container: A annealed aluminium tube with internal laquer, fitted with a tamper evident

HDPE cap, with cardboard outer carton.

Contents: Each tube contains 5ml.

No special precautions.

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

PL 0587/5003R

31/09/90 / 22/2/96

13/06/2006