国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Zinc undecylenate; Undecylenic acid
Clonmel Healthcare Ltd
D01AE; D01AE04
Zinc undecylenate; Undecylenic acid
20/2 percent weight/weight
Cutaneous powder
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 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Desenex Powder Zinc undecylenate 20% w/w Undecylenic Acid 2.0% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc Undecylenate 20.0 % w/w Undecylenic Acid 2.0 % w/w Excipients with known effect Also includes benzyl benzoate maximum 0.25% w/w. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous powder (powder). White free-flowing powder, free from lumps and grit. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desenex is recommended in the prophylaxis and treatment of mycotic superficial dermatophytoses of feet and 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 Desenex Powder liberally over the affected areas as required after washing and drying. _Feet:_ Twice daily, sprinkle powder liberally between toes, on feet, and in the shoes and socks. 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. 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 notified. Health Products Regulatory Authority 26 June 2020 CRN009671 Page 2 of 4 Desenex Powder contains benzyl benzoate which may cause local irritation. Do not apply to broken skin 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None stated. 4 阅读完整的文件