PRODUCT SUMMARY

1.    NAME OF THE MEDICINAL PRODUCT

Carnation Corn Caps Boots Corn Removal Plasters Superdrug Medicated Corn Plasters Tesco Medicated Corn Treatment Lloydspharmacy Medicated Corn Plasters

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Salicylic Acid 40% w/w

3.    PHARMACEUTICAL FORM

Dressings with centre ring containing Salicylic Acid Paste.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the removal of hard corns.

4.2    Posology and method of administration

One Medicated Dressing to be applied to the    corn every two days. Treatment

comprises a medicated dressing for topical application. A medicated dressing is placed over the corn, left in place for 2 days and removed. The area is cleaned and any loose skin removed. Treatment is continued until the corn removes easily.

A maximum of 5 corn caps should be used per corn.

No more than 3 corns should be treated at one time.

Children: Children under 15 should consult their doctor before use.

4.3 Contra indications

1.    Not to be used by diabetics. Patients with severe circulatory disorders should seek professional medical advice.

2.    Do not use if corn or surrounding skin is inflamed or broken.

3.    Do not apply to normal skin or use for any other purpose.

No Data Held

4.4 Special warnings and special precautions for use

1.    Discontinue use and remove dressing if excess discomfort or irritation is experienced, or if sensitivity develops.

2.    If symptoms persist seek professional medical advice.

3.    Contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to Peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid using this product.

4.5 Interactions with other medicinal products and other forms of interaction

None with other medicaments. Absorbed salicylic acid may theoretically interfere with assays for theophylline at low concentration.

4.6 Pregnancy and lactation

No specific data.

4.7 Effects on ability to drive and use machines

Not applicable.

Undesirable effects

Mild discomfort / soreness.

4.9 Overdose

Not applicable.

5.    Pharmacological Properties

5.1    Pharmacodynamic properties

Salicylic Acid

Salicylic acid has keratolytic properties and externally applied it produces a slow destruction of the epithelium. The epidermis desquamates making the underlying layer more accessible to debridement.

5.2    Pharmacokinetic properties

Formulation designed to provide gradual release of salicylic acid to restricted area of corn. It is absorbed into the outer epidermis.

5.3    Preclinical safety data

Not applicable.

6.    Pharmaceutical Particulars

6.1    List of excipients

Yellow Beeswax BP

Staybelite Resin (partially hydrogenated wood resin) Arachis Oil BP

Softisan 378 (vegetable triglyceride)

Red Paste 28904 (E124; E110)

6.2    Incompatibilities

None known.

6.3    Shelf life

36 months.

6.4 Special precautions for storage

Store at less than 30°C, away from direct sources of heat and humidity.

6.5 Nature and contents of container

Printed cardboard wallet or flow wrap bag, containing 4, 5 or 10 corn caps. Supplied in multiple of 30 wallets in cardboard outers.

6.6 Instructions for use, handling and disposal

No special instructions apply.

ADMINISTRATION DATA

7. MARKETING AUTHORISATION HOLDER

Cuxson Gerrard & Company Limited 125 Broadwell Road

OLDBURY West Midlands B69 4BF United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 00089/5007R.

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

24 November 1988 / 1 December 1998

10. DATE OF (PARTIAL) REVISION OF TEXT

March 2005