国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE HYDROUS POTASSIUM HYDROXYQUINOLIN SULFATE
Ferndale Pharmaceuticals Ltd
5 + 0.5 %w/w
Cream
2002-02-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinoderm 5% w/w + 0.5% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Also includes cetostearyl alcohol, approximately 0.825% w/w . For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A creamy white astringent vanishing cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acne Vulgaris, Acneform eruptions, Folliculitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration For topical use only. Adults, Children and the Elderly By gentle massage over the affected area two or three times daily. A single course of treatment should not extend beyond three months unless there is clear evidence of response 4.3 CONTRAINDICATIONS Acne Rosacea. Patients with known sensitivity to either of the active ingredients should not use Quinoderm Cream 5. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness. In the few isolated cases, overreaction to Quinoderm Cream may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment and a physician or pharmacist should be consulted. A single course of treatment should not extend beyond three months unless there is clear evidence of response _(see section 4.2,_ _posology and method of administration)._ The product should only be used with caution in areas of thin or sensitive skin. Fair skinned individuals are likely to be particularly sensitive to irritation. Benzoyl Peroxide should not be used in patients with fair or sensitive skin 阅读完整的文件