Corn And Callous Salve
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Com and Callous Salve
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid EP 12.50%w/w
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of corns and callouses.
4.2 Posology and method of administration
Cutaneous use.
Adults and children over 16 years: apply salve directly to corn or callous every two
days until the corn or callous can easily be removed. Treatment to be continued for up to two weeks, except under medical advice.
No distinction is made between different categories of patient.
Children: not recommended for children under sixteen years, except following a doctor’s recommendation.
4.3 Contraindications
Not to be used by diabetics or patients with severe circulatory disorders, except following a doctor’s permission and recommendation.
Not to be used if corn, callous or surrounding skin is inflamed or broken.
Not to be used in patients who are hypersensitive to salicylic acid or to any ingredient in the preparation.
4.4 Special warnings and precautions for use
Discontinue use and remove any dressing if excessive discomfort or irritation is experienced, or if sensitivity develops.
Do not apply to normal skin.
If the salve comes into contact with normal skin wash off immediately with copious amounts of water.
Unsuitable for soft corns between the toes.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6
Pregnancy and lactation
Safety of use in 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 or dermatitis may occur.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Wart and anti-corn preparations
ATC code: D11AF
Keratolytic agent
5.2 Pharmacokinetic properties
Not applicable for a topical dosage form.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anhydrous lanolin
Eucalyptus oil
6.2 Incompatibilities
None stated.
6.3 Shelf life
4 years unopened.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Container: Epoxy lined aluminium tube with plastic cap, packed into outer carton.
Contents: Each tube contains 5g.
7 MARKETING AUTHORISATION HOLDER
AYRTON SAUNDERS LIMITED NORTH WAY
WALWORTH INDUSTRAIL ESTATE
ANDOVER
SP10 5AZ
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0144
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/9/1990 / 22/3/1996
10 DATE OF REVISION OF THE TEXT
08/03/2008