Scholl Complete Corn Treatment Kit

1. Name Of The Medicinal Product

Scholl Complete Corn Treatment Kit

2. Qualitative And Quantitative Composition

Salicylic Acid 40% w/w.

3. Pharmaceutical Form

Medicated adhesive plaster.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of corns.

4.2 Posology And Method Of Administration

Adults: For best results, the feet should be washed and dried before use. One medicated disc should be placed on the corn, covered with a cover plaster. This should be repeated daily until the corn can be removed. Treatment should not continue for more than two weeks. No distinction is made between different categories of patient. Children: Not recommended for children under sixteen, except following a doctor's recommendation.

4.3 Contraindications

Not to be used on diabetics or those with severe circulatory disorders, except following a doctor's permission and recommendation. Not to be used by those sensitive to salicylic acid or any of the other constituents of the product. Not to be used if the corn or surrounding skin is broken or inflamed.

4.4 Special Warnings And Precautions For Use

Discontinue use and remove plaster if excessive discomfort is experienced. Do not apply to normal skin. For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not relevant to cutaneous use.

4.6 Pregnancy And Lactation

Safety and use in pregnancy and during 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

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Classification (ATC): D11 AF. Salicylic Acid: Keratolytic agent.

5.2 Pharmacokinetic Properties

Not relevant to topical dosage form.

5.3 Preclinical Safety Data

No other information relevant to the prescriber other than that already stated in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyvinyl Alkyl Ether (Low Molecular Weight); Polyvinyl Alkyl Ether (High Molecular Weight); Titanium Dioxide; Liquid Paraffin; 4,4'-thio-bis-2-tert-butyl-5-methylphenol; Red Iron Oxide; Black Iron Oxide; Backing material.

6.2 Incompatibilities

Not relevant.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25^oC. Keep out of the reach of children.

6.5 Nature And Contents Of Container

Sachet contents: 6 medicated adhesive discs mounted onto a silicone backed paper.

6 Twill cloth cover plasters with pressure sensitive adhesive mounted onto a silicone backed paper.

9 foam corn cushions mounted onto a silicone backed paper.

Outer container: cardboard carton or polypropylene flow wrap.

6.6 Special Precautions For Disposal And Other Handling

Apply with medicated disc to centre of corn, fabric side uppermost. Cover with pad.

7. Marketing Authorisation Holder

Scholl Consumer Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 0587/5015R.

9. Date Of First Authorisation/Renewal Of The Authorisation

17^th September 1990 / 13^th December 2004

10. Date Of Revision Of The Text

July 2005