1. Name Of The Medicinal Product
Athlete's Foot Cream; Mycota Cream.
2. Qualitative And Quantitative Composition
Zinc Undecylenate Ph. Eur. 20.0% w/w.
Undecylenic Acid Ph. Eur. 5.0% w/w.
For full list of excipients, see section 6.1.
3. Pharmaceutical Form
Cream for topical administration.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment and prevention of athlete's foot.
4.2 Posology And Method Of Administration
Adults, Children and Elderly
Treatment
Each night and morning wash thoroughly dry the foot, then smooth the cream on to the affected area. Take particular care to ensure the cream is massaged between the toes then dust with Mycota Powder. Wear clean socks or stockings each day dusted inside with Mycota Powder. Continue this treatment for one week after all signs of infection have disappeared.
Prevention
Each day rub in Athlete's Foot Cream and dust socks or stockings inside with Mycota Powder.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
The label states for external use only, keep all medicines out of the reach and sight of children.
Contact with the eyes and mucous membranes should be avoided.
Treatment should be discontinued if irritation is severe.
Do not apply to broken skin.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant drug interactions known.
4.6 Pregnancy And Lactation
Although there is no specific data available concerning the use of Athlete's Foot Cream during pregnancy and lactation, it is not considered to constitute a hazard.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
Hypersensitivity reactions may occasionally occur. Irritation of the skin may rarely occur.
4.9 Overdose
Excessive application to the skin is unlikely to cause untoward effects. In the unlikely event of ingestion of Athlete's Foot Cream symptoms of overdosage may include nausea, vomiting, diarrhoea and general gastrointestinal disturbances. Treatment need only be symptomatic.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Undecylenic Acid and Zinc Undecylenate have antifungal and antibacterial properties.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Liquid Paraffin Ph. Eur.
Emulsifying Wax BP
Perfume Compound 11899 NAROM HSE
Purified Water Ph. Eur.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
Collapsible aluminium internally lacquered tube containing either 3g, 4g, 5g, 25g, 30g, 35g or 40g of cream, fitted with a polypropylene plug seal.
Combination pack of one tube of each pack size with one 70g pack of Mycota Powder in a printed carton.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
8. Marketing Authorisation Number(S)
PL 00240/0064
9. Date Of First Authorisation/Renewal Of The Authorisation
13th August 2003
10. Date Of Revision Of The Text
10 February 2009
11 DOSIMETRY
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not Applicable
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