Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE
Ferndale Pharmaceuticals Ltd
5% %w/w
Cream
2005-06-24
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benzoyl Peroxide Cream 5 % 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzoyl Peroxide 5 % w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream Creamy, white thixotropic cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acne Vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. Adults, children and the elderly: By gentle massage over all the affected area two or three times daily. 4.3 CONTRAINDICATIONS Acne Rosacea. Patients with known sensitivity to Benzoyl Peroxide. 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. Individuals may notice dry skin. In a few isolated cases, overreaction to Benzoyl Peroxide Cream 5% 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 redness occurs, do not proceed with the treatment. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Benzoyl Peroxide is an oxidising agent. Hence, Benzoyl Peroxide Cream 5% should not be used at the same time as other topical agents which would react with an oxidising agent. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/07/2006_ _CRN 2025780_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Benzoyl Peroxide Cream 5% is not contra-indicated in pregnancy or lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS If symptoms persist or if the condition worsens or if irritation, itch or rash occurs, treatment shou Read the complete document