Scholl Corn Removal Plasters (Fabric)

1. Name Of The Medicinal Product

Scholl Corn Removal Plasters (Fabric).

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 on the feet.

4.2 Posology And Method Of Administration

Adults: One medicated plaster to be applied to the corn daily until the corn can be removed. Treatment to be continued for up to 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 or irritation is experienced or if sensitivity develops. Do not apply to normal skin.

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

None stated.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Salicylic Acid: Keratolytic agent

5.2 Pharmacokinetic Properties

Not applicable for a 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 SPC.

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.

6.5 Nature And Contents Of Container

Container: Sachet (polyvinylidene coated polypropylene film).

Plasters:

Sachet contents: 4, 6 or 8 medicated adhesive plasters mounted onto a silicone backed paper. 4, 6, or 8 cover plasters mounted onto a silicone backed paper.

Pads:

Sachet Contents: 2, 4 or 6 medicated adhesive discs mounted onto a silicone backed paper. 2, 4 or 6 twill cloth or silicone “polymer gel” cover pads with pressure sensitive adhesive mounted onto a silicone backed paper.

Outer container: polypropylene flow wrap or cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

Apply medicated disc to corn fabric side uppermost. Cover with pad and fix with strap.

7. Marketing Authorisation Holder

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

8. Marketing Authorisation Number(S)

PL 0587/5014R.

9. Date Of First Authorisation/Renewal Of The Authorisation

9^th August 1990 / 9^th June 2004

10. Date Of Revision Of The Text

July 2005