Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Zinc undecylenate; Undecylenic acid
Clonmel Healthcare Ltd
D01AE; D01AE04
Zinc undecylenate; Undecylenic acid
20/5 percent weight/weight
Ointment
Product not subject to medical prescription
Other antifungals for topical use; undecylenic acid
Marketed
1998-03-20
Health Products Regulatory Authority 26 June 2020 CRN009671 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Desenex Ointment Zinc Undecylenate 20% w/w Undecylenic Acid 5% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc Undecylenate 20.0 % w/w Undecylenic Acid 5.0 % w/w Excipients with known effect Contains wool fat 3.0 % w/w, methyl parahydroxybenzoate (E218) 0.3 % w/w, propyl parahydroxybenzoate (E216) 0.075 % w/w and benzyl benzoate (Max 0.25% w/w). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment A white to cream coloured smooth ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desenex is recommended in the prophylaxis and treatment of mycotic superficial dermatophytoses of feet and the relief of itching and scaling produced by these fungal infections. Is it also used to remove foot odour and prevent sweating. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: For topical administration only. _General directions_: Apply a smooth even coating of ointment to affected areas as required or use as directed by the physician _Feet:_ Twice daily, wash and dry the infected area, apply ½ inch (12.7 mm) ribbon of ointment and rub gently between toes and on feet. Spread evenly. Continue treatment for two weeks after symptoms disappear. If there is no improvement after 2 weeks treatment or symptoms worsen consult your doctor or pharmacist. To prevent reinfection, use Desenex Powder daily. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not recommended for nail or scalp infections. Do not use on children under 2 years of age, except under the advice and supervision of a doctor. Health Products Regulatory Authority 26 June 2020 CRN009671 Page 2 of 5 If there is no response within 2 weeks, or the condition is aggravated, use of the product should be stopped and the physician should be consulted. Desenex ointment contains methyl parahydrox Citiți documentul complet