Miconol Miconazole nitrate 2 gm/100gm Topical Cream SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MICONOL 2% TOPICAL CREAM 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Miconazole nitrate 2% w/w. (Each 100 gm contains 2 gm of Miconazole nitrate) For the full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM White smooth homogenous topical cream free from foreign matter. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria. 4.2 Posology and method of administration Route of administration: Cutaneous use. Recommended dosage: For all ages: Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. If the powder is used with the cream, a once daily application of both formulations is recommended. The duration of therapy varies from 2 to 6 weeks depending on the localisation and the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms. Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse. 4.3 Contraindications Miconol cream is contraindicated in individuals with a known hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives or to any of the excipients listed in
