Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
WHITE SOFT PARAFFIN
Alliance Pharmaceuticals Ltd.
10 %w/w
Unknown
2006-09-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dermamist 10% w/w Dry Skin Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION White soft paraffin 10.0% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Spray, solution (cutaneous spray) A cutaneous spray delivering white soft paraffin as a clear colourless spray by means of a pressurised aerosol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of dry skin conditions including pruritus(itching and dryness) of the elderly eczema, and ichthyosis(dry scaly skin). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, children and the elderly: Shake before use. Bathe or shower for not more than ten minutes. Pat dry and apply spray without delay. Do not spray on face. Spray from a distance of approximately 8 inches. Spray away from the face and move the can while spraying to achieve a very light coverage of the body. Spray sparingly; over application may cause the skin to feel oily. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Keep out of reach of children. Do not spray on face. Use in a ventilated area. Avoid inhalation. Guard against slipping. Discontinue use if the condition is made worse. Do not apply to broken skin. Patients being dispensed or treated with large quantities (> 100g) of any paraffin based product shoudl be advised to regularly change clothing or bedding impregnated with the product and keep away from naked flames as there is a fire hazard. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 03/03/2011 read_full_document