Bells Corn & Callus Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BELL’S CORN & CALLUS OINTMENT
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid BP 12.5 % w/w
3 PHARMACEUTICAL FORM
OINTMENT
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A remedy to aid in the removal of corns, callouses and hard skin.
4.2 Posology and method of administration
Adults, Elderly and Children: Apply to the affected small areas of the feet at bedtime. Cover them if necessary. Wash in warm to hot water in the morning.
4.3 Contraindications
Contraindicated in patients known to be sensitive to Salicylic Acid and also those who suffer from asthma.
Bell’s Corn & Callus Ointment should not be used by diabetics or patients with impaired blood circulation. Do not use if the corn or callous or surrounding skin is inflamed or broken. Do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or in the anal or perineal region.
4.4 Special warnings and precautions for use
Bell’s Corn & Callus Ointment is for external use only. Do not permit contact with eyes or mucous membranes. If contact occurs flush with water for 15 minutes. Do not allow contact with normal skin around corn or callous. Avoid using on areas of broken or damaged skin. Discontinue treatment if excessive irritation occurs. Excessive prolonged use of topical salicylic acid may result in symptoms of salicylism and must therefore be avoided.
Keep medicines away from children. Wash hands after use.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Pregnancy and lactation
May be used.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
May cause hypersensitivity reactions, skin rashes and dermatitis.
Undesirable effects are listed by MEDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings:
Very common: >1/10
Common:>1/100 to <1/10
Uncommon:>1/1000 to <1/100
Rare:> 1/10000 to <1/1000
Very rare:<1/10000
Not known: cannot be estimated from the available data
System Organ Class
Undesirable Effect
Frequency
*A localised irritant reaction may occur if Bell’s Corn & Callus Ointment is applied to normal skin surrounding the corn or callous. This may normally be controlled by temporarily discontinuing the use of Bell’s Corn & Callus Ointment and by being careful to apply the solution only to the corn or callous itself when treatment is resumed.
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.
4.9 Overdose
Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Bell’s Corn & Callus Ointment is used as indicated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Salicylic Acid is keratolytic.
5.2 Pharmacokinetic properties
No information available.
5.3
|
Skin and subcutaneous tissue disorders |
Skin irritation* |
Not known |
|
Injury, poisoning and procedural complications |
Salicylism (including tinnitus) |
Not known |
Preclinical safety data
No information available.
6.1 List of excipients
Maize Starch, Liquid Paraffin, Chlorophyll Oil-Soluble, Yellow Soft Paraffin.
6.2 Incompatibilities
None.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
Glass jar with wadded hard plastic screwcap: 25 g. Double-wall polyethylene pot with hard plastic screwcap: 25 g.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Bell Sons and Company (Druggist) Limited
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
United Kingdom
MARKETING AUTHORISATION NUMBER(S)
PL 03105/0084
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/05/1990
DATE OF REVISION OF THE TEXT
08/11/2016