Scholl Callous Removal Pads

1. Name Of The Medicinal Product

Scholl Callous Removal Pads.

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 callouses.

4.2 Posology And Method Of Administration

Adults: One medicated plaster to be applied to the callous daily until the callous can 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, 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 callous 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

None stated.

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

Salicylic acid: Keratolytic agent.

5.2 Pharmacokinetic Properties

Not applicable to a topical dosage form.

5.3 Preclinical Safety Data

No further data relevant to the user.

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

Shelf life in products containing the medicated adhesive packaged for sale: 3 years. Shelf life after opening: 6 weeks.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

One sachet containing 2, 4 or 6 medicated adhesive discs. Each pack includes one strip of ecru coloured twill cover plasters covered with a pressure sensitive adhesive on one side for the standard product, or a reusable, translucent polymer gel cover plaster which is naturally tacky on one side, for 'the polymer gel' variant. The sachet and cover plasters are flow wrapped in polypropylene film or packed in cardboard cartons.

6.6 Special Precautions For Disposal And Other Handling

Apply medicated disc to callous fabric side uppermost.

7. Marketing Authorisation Holder

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

8. Marketing Authorisation Number(S)

PL 0587/5000R.

9. Date Of First Authorisation/Renewal Of The Authorisation

17^th September 1990 / 16^th January 2004

10. Date Of Revision Of The Text

January 2004