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Corn And Callous Salve

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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