Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LIQUID PARAFFIN LIGHT, ISOPROPYL MYRISTATE
Merck Sharp & Dohme Ireland (Human Health) Limited
A06AA51
LIQUID PARAFFIN LIGHT, ISOPROPYL MYRISTATE
46/39 %w/w
Bath Additive
Product not subject to medical prescription
Softeners, emollients
Authorised
2010-11-26
Ireland 1 PACKAGE LEAFLET: INFORMATION FOR THE USER DIPROBATH 46% W/W AND 39% W/W BATH ADDITIVE Light liquid paraffin and Isopropyl myristate READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice - You must contact your doctor if your symptoms worsen. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Diprobath is and what it is used for 2. Before you use Diprobath 3. How to use Diprobath 4. Possible side effects 5. How to store Diprobath 6. Further information 1. WHAT DIPROBATH IS AND WHAT IT IS USED FOR Diprobath is a bath additive. It helps to soothe and soften the skin. Diprobath leaves a thin film of oil over the skin and helps to prevent the skin drying out. It is used to treat dry skin conditions and conditions where the skin is thickened and scaly, such as in dermatitis and eczema. Dermatitis is inflammation of the skin. Eczema is a common skin disease, which causes the skin to become red and itchy. 2. BEFORE YOU USE DIPROBATH DO NOT USE DIPROBATH - if you are allergic (hypersensitive) to any of the other ingredients of Diprobath. 3. HOW TO USE DIPROBATH Always use Diprobath exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. TAKE CARE ON GETTING IN AND OUT OF THE BATH BECAUSE IT MAY BE MORE SLIPPERY THAN USUAL. For a full bath (100 litres) add 25ml (approximately 2.5 capfuls) to the bathwater and mix. For a child’s bath (25-30 litres) add Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diprobath 46% w/w and 39% w/w Bath Additive 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Light Liquid Paraffin 46.0% w/w Isopropyl Myristate 39.0% w/w For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Bath additive Clear, colourless, oily liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of dry skin conditions and other hyperkeratoses including those associated with dermatitis and eczema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be applied externally, diluted in a bath of water. Adults including elderly patients: 25 ml or approximately 2.5 capfuls to be diluted in a bath of water (100:1 approximately). For particularly dry skin, the quantity of oil emollient may be doubled. 10ml or one capful is sufficient for children’s bath. Frequency and duration of bathing will depend on the type and severity of the conditions, but generally 2 to 3 baths should be taken weekly. 4.3 CONTRAINDICATIONS Known sensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As Diprobath deposits a film of oil over the skin, care should be taken to avoid slipping in the bath. The following warning will appear on the label: “Take care when entering or leaving the bath which may be more slippery than usual”. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/04/2014_ _CRN 2145891_ _page number: 1_ 4.6 FERTILITY, PREGNANCY AND LACTATION No special precautions. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS None known. 4.9 OVERDOSE Not applicable. Read the complete document