Thursday, September 8, 2016

Scholl Corn Removal Plasters (Washproof)





1. Name Of The Medicinal Product



Scholl Corn Removal Plasters (Washproof).


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 is experienced. 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.



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 25oC.



6.5 Nature And Contents Of Container



Container: Sachet (polyvinylidene coated polypropylene film). One sachet containing 4 medicated adhesive discs and one strip of cover plasters flow wrapped in polypropylene film or packed in cardboard cartons.



6.6 Special Precautions For Disposal And Other Handling



Apply medicated disc with adhesive side to the skin. 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



9th August 1990 / 9th June 2004



10. Date Of Revision Of The Text



July 2005




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