Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isopropyl myristate; Benzalkonium chloride; Liquid paraffin
Dermal Laboratories Ltd
n/a
Isopropyl myristate; Benzalkonium chloride; Liquid paraffin
250mg/1gram ; 5mg/1gram ; 250mg/1gram
Bath additive
Cutaneous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 13020101; GTIN: 5016379153006
PACKAGE LEAFLET _Information for the user_ PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information or advice. IN THIS LEAFLET: 1. What Dermol 600 Bath Emollient is and what it is used for 2. Before you use Dermol 600 Bath Emollient 3. How to use Dermol 600 Bath Emollient 4. Possible side effects 5. How to store Dermol 600 Bath Emollient 6. Further information 7. General advice on looking after dry skin conditions 1. WHAT DERMOL 600 BATH EMOLLIENT IS AND WHAT IT IS USED FOR • Dermol 600 Bath Emollient is an antimicrobial and emollient (softening and moisturising) skin treatment for you to add to your bath water when bathing. • It helps to treat and prevent dry and itchy (pruritic) skin conditions, especially eczema and dermatitis. • ALL AGE GROUPS can use Dermol 600 Bath Emollient, including babies. • There are two types of ACTIVE INGREDIENT in this product: – Benzalkonium chloride is an ANTIMICROBIAL. This helps to: – combat bacteria present on your skin that can make eczema worse – prevent infection caused by scratching itchy skin. – Liquid paraffin and isopropyl myristate are EMOLLIENTS which help to: – soften, moisturise and protect your skin by trapping moisture in the skin and restoring the normal protective function of the skin – prevent the skin-drying and irritant effects that can be caused by washing and bathing and by the soaps, foaming additives and fragrances used in ordinary skin cleansing products. • This product can be used in addition to any other emollients or treatments your doctor or pharmacist may have given or prescribed for you to treat your dry skin condition. 2. BEFORE YOU USE DERMOL 600 BATH EMOLLIENT DO NOT USE this product if you are ALLERGIC (hypersensitive) to benzalkonium chloride, liquid paraffin, isopropyl myristate, or any of the other ingredients of Dermol 600 Bath Emollient listed in Section 6. WARNINGS AND PRECAUTIONS Do not Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dermol 600 Bath Emollient. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Benzalkonium Chloride 0.5% w/w Liquid Paraffin 25.0% w/w Isopropyl Myristate 25.0% w/w For excipients see Section 6.1. 3. PHARMACEUTICAL FORM White Bath additive. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS An antimicrobial bath emollient for use as an aid in the treatment of dry and pruritic skin conditions, especially eczema/dermatitis, ichthyosis or xeroderma. It permits the rehydration of the keratin by replacing lost lipids, and its antiseptic properties assist in overcoming secondary infection. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For use in the bath: Adults, elderly and children: Add up to 30 ml to a bath of warm water (more or less according to the size of the bath and individual patient requirements). Infants: Add up to 15 ml to a bath of warm water (more or less according to the size of the bath and individual patient requirements). Soak for 5 - 10 minutes. Pat dry. 4.3. CONTRAINDICATIONS Sensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Keep away from the eyes. For external use only. Keep out of the sight and reach of children. Take care to avoid slipping in the bath. Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6. PREGNANCY AND LACTATION No special precautions. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Although the bath emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment. These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irrit Прочетете целия документ