Mycota

Mycota Cream

Zinc Undecylenate Ph. Eur. 20.0% w/w

Undecylenic Acid Ph. Eur. 5.0% w/w

Excipient(s) with known effect:

Perfume Compound 11899 Narom (Contains Euganol) HSE 0.2% w/w

Emulsifying Wax (Contains Cetostearyl alcohol and Sodium laurilsulfate) BP 15.0 % w/w

For full list of excipients, see section 6.1

Cream for topical administration

For the treatment and prevention of athlete's foot

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 Mycota Cream and dust socks or stockings inside with Mycota Powder.

Hypersensitivity to any of the ingredients

The label states for external use only, keep all medicines out of the sight and reach 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.

Excipient warnings:

This medicine contains Emulsifying wax with 1.4% w/w Sodium laurilsulfate. Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.

This medicine contains Emulsifying wax with 1.36% w/w Cetostearyl alcohol. Cetosteryl alcohol may cause local skin reactions (e.g. contact dermatitis).

This medicine contains fragrance with Euganol, which may cause an allergic reaction.

No clinically significant drug interactions known

Although there is no specific data available concerning the use of Mycota Cream during pregnancy and lactation, it is not considered to constitute a hazard.

No adverse effects known

Hypersensitivity reactions may occasionally occur. Irritation of the skin may rarely occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Excessive application to the skin is unlikely to cause untoward effects. In the unlikely event of ingestion of Mycota Cream symptoms of overdosage may include nausea, vomiting, diarrhoea and general gastrointestinal disturbances. Treatment need only be symptomatic.

Undecylenic Acid and Zinc Undecylenate have antifungal and antibacterial properties.

None stated

Not applicable

Liquid Paraffin Ph. Eur.

Emulsifying Wax BP (Contains Cetostearyl alcohol and Sodium laurilsulfate)

Perfume Compound 11899 NAROM HSE (Contains Euganol)

Purified Water Ph. Eur.

Not applicable

36 months

None

Collapsible aluminium internally lacquered tube containing 25g of cream, fitted with a polypropylene plug seal

Not applicable

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

PL 00240/0064

13/08/2003

06/10/2020