Symptoms
Salicylic acid is readily absorbed through the skin, and symptoms of acute systemic salicylate poisoning have been reported after excessive use. Symptoms include thirst, lethargy, dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, tachypnoea, psychiatric disturbances and confusion.
Camphor is readily absorbed through the skin but the volume of absorption is relatively low. However, if accidental overdose does occur it can lead to nausea, vomiting, epigastric pain, headache, dizziness, oropharyngeal burning, delirium, muscle twitching, epileptiform convulsions, depression of the CNS and coma.
Management
In cases of overdose the product should be discontinued and supportive treatment given, this may include anticonvulsant therapy.
Bottles: 5 years
Aluminium Tubes: 2 years
Not to be used by diabetics or those with severe circulatory disorders or suffering from neuropathy, except following a doctor's permission and recommendation.
Not to be used if the corn, callous, wart, verruca or surrounding skin is broken or inflamed.
Not to be used by pregnant or breastfeeding patients
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, mucosa or large areas of the body.
Not to be used in children under 12 years.
Not relevant
Pyroxylin HSE
Virgin Castor Oil EP
Methoxyisopropanol HSE
Acetone EP
Topical solution
Local irritation or dermatitis may occur. if applied to normal healthy skin surrounding the callous. This may be controlled by temporarily discontinuing use and by carefully applying only to the verruca, corn or callus when the treatment is resumed.
Adverse events which have been associated with salicylic acid and camphor are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (>1/10); Common (>1/100 and <1/10) Uncommon (>1/1000 and <1/100); Rare (>1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
|
System Organ Class |
Frequency |
Adverse Events |
|
Immune System Disorders |
Not Known |
Hypersensitivity 1 |
|
Skin and Subcutaneous Tissue Disorders |
Not Known |
Dermatitis Contact |
|
General Disorders and Administration Site Conditions |
Not Known |
Application Site Reaction |
Description of Selected Adverse Reactions
1 Hypersensitivity reactions include urticaria, anaphylaxis and erythema multiforme.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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 50mg/kg to 500mg/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.
For the treatment of corns, calluses, common warts and plantar warts (verrucas).
Pharmacotherapeutic group: Other dermatological preparations; Wart and anti-corn preparations; ATC classification is D11 AF.
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.
18/01/2017
Scholl Corn and Callous Removal Liquid
Scholl Medicated Corn and Callous Removal Liquid
Seal and Heal Verruca Removal Gel
Scholl Consumer Products Ltd
103-105 Bath Road
Slough
SL1 3UH
UK
Do not store above 25°C
Keep out of the reach of children
Container: Glass bottle fitted with a polypropylene tamper evident cap and applicator
Contents: Each bottle contains 10ml
Container: An annealed aluminium tube with internal laquer, fitted with a tamper evident HDPE cap, with cardboard outer carton
Contents: Each tube contains 5ml
PL 00587/5003R
Pregnancy:
There is no data on the use of topical salicylic acid or camphor 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 camphor in breast feeding women. Therefore the use of this product during breast feeding is contraindicated.
Fertility:
There is no information on the effects of topical salicylic acid or camphor and fertility.
| Ingredient | % w/w |
| Salicylic Acid EP | 12.50 |
| Camphor BP | 3.11 |
Discontinue use and remove any dressing if excessive discomfort or irritation is experienced or if sensitivity develops.
If the liquid comes into contact with normal skin wash off immediately with copious water.
Do not apply to normal skin or skin which is inflamed or broken.
For external use only.
This product contains the excipient Caster Oil which may cause skin reactions.
None stated
Posology
Treatment may be continued for up to twelve weeks except on medical advice.
Adults:
Apply directly to the callus, corn, verruca or wart twice a day.
Paediatric Population
Children over 12 years:
As above for adults.
Children aged under 12 years of age:
Not recommended for children under twelve.
Method of Administration
For best results the feet should be washed and dried before use. The healthy skin around the area to treat should be protected with soft paraffin. 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.
No distinction is made between different categories of patient.
No special precautions
31/09/1990
Salicylic acid can increase the penetration of topical drugs into the skin.
