Friday, October 21, 2016

Boots Corn Removal Plasters





1. Name Of The Medicinal Product



Carnation corn caps



Boots Corn Removal Plasters


2. Qualitative And Quantitative Composition






Salicylic Acid




40.0% 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 Contraindications












1.




Not to be used by diabetics or patients with severe circulatory disorders, except following a doctor's permission or recommendation.




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.




4.




Do not use if hypersensitive to salicylic acid or any of the components of the preparation.



4.4 Special Warnings And 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 Interaction With Other Medicinal Products And Other Forms Of Interaction



There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines



Concomitant use of this product and other topical medicines on the same corn should therefore be avoided.



4.6 Pregnancy And Lactation



Whilst there are no known contra-indications to the use of this product during pregnancy and lactation, the safety has not been established. Use should therefore be used with caution or following professional medical advice.



4.7 Effects On Ability To Drive And Use Machines



Not applicable.



4.8 Undesirable Effects



A localised irritant reaction may occur if applied to normal skin surrounding the corn. This may be controlled by temporarily discontinuing use and by carefully applying only to the corn when the treatment is resumed.



4.9 Overdose



Not applicable.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



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



Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of this product.



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



Yellow Beeswax



Arachis Oil



Softisan 378 (Vegetable Triglyceride)



Red Paste 28904 (E.124; E.110)



Staybelite Resin (partially hydrogenated wood resin)



6.2 Incompatibilities



None known



6.3 Shelf Life



36 months



6.4 Special Precautions For Storage



Store at less than 30ÂșC, 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 Special Precautions For Disposal And Other Handling



No special instructions apply.



7. Marketing Authorisation Holder



Cuxson Gerrard & Company Limited



125 Broadwell Road



OLDBURY



West Midlands B69 4BF



United Kingdom



8. Marketing Authorisation Number(S)



PL 00089/5007R.



9. Date Of First Authorisation/Renewal Of The Authorisation



24 November 1988 / 6 November 2003



10. Date Of Revision Of The Text



December 2007




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