Sunday, September 2, 2012

Scholl Athlete's Foot Powder





1. Name Of The Medicinal Product



Scholl Athlete's Foot Powder.


2. Qualitative And Quantitative Composition



Tolnaftate BP 1.0% w/w.



3. Pharmaceutical Form



Powder for topical application.



4. Clinical Particulars



4.1 Therapeutic Indications



Prevention and treatment of Athlete's Foot.



4.2 Posology And Method Of Administration



Wash and dry infected area and apply twice daily, or as directed by a doctor. Dust feet liberally, especially between toes. For added protection dust on socks, hosiery and inside shoes. Continue treatment for two weeks after symptoms disappear.



4.3 Contraindications



Not recommended for nail or scalp infections.



4.4 Special Warnings And Precautions For Use



Keep out of the reach of children. For external use only. Keep out of the eyes. If symptoms do not improve within 10 days, discontinue use and consult your doctor.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Not relevant to topical use.



4.6 Pregnancy And Lactation



No known restrictions.



4.7 Effects On Ability To Drive And Use Machines



None stated.



4.8 Undesirable Effects



None stated.



4.9 Overdose



Not relevant to topical use.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Tolnaftate: topical antifungal agent (ATC Classification D01AE).



5.2 Pharmacokinetic Properties



Not applicable for a topical dosage form of this type.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Talc; Starch.



6.2 Incompatibilities



None stated.



6.3 Shelf Life



5 years.



6.4 Special Precautions For Storage



Store below 25oC.



6.5 Nature And Contents Of Container



High density poly-ethylene powder bottle with sifter assembly. Pack size: 75g



6.6 Special Precautions For Disposal And Other Handling



No special precautions required.



7. Marketing Authorisation Holder



Scholl Consumer Products Ltd. Venus, 1 Old Park Lane, Trafford Park, Manchester M41 7HA



8. Marketing Authorisation Number(S)



PL 0587/0007



9. Date Of First Authorisation/Renewal Of The Authorisation



24th April 1985 / 13th January 2005



10. Date Of Revision Of The Text



May 2006




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