Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Liquid paraffin; Isopropyl myristate; Benzalkonium chloride; Chlorhexidine hydrochloride
Dermal Laboratories Ltd
D02AX
Liquid paraffin; Isopropyl myristate; Benzalkonium chloride; Chlorhexidine hydrochloride
100mg/1gram ; 100mg/1gram ; 1mg/1gram ; 1mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 13020100; GTIN: 5016379156106 5016379156007
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 Cream is and what it is used for 2. Before you use Dermol Cream 3. How to use Dermol Cream 4. Possible side effects 5. How to store Dermol Cream 6. Further information 7. General advice on looking after dry skin conditions 1. WHAT DERMOL CREAM IS AND WHAT IT IS USED FOR • Dermol Cream is an antimicrobial and emollient (softening and moisturising) treatment for application to dry or problem skin. • It is for use in two ways: – as a leave-on application – as a soap-substitute. • It helps treat and prevent dry and itchy (pruritic) skin conditions, especially eczema and dermatitis. • ALL AGE GROUPS can use Dermol Cream, including babies. • There are two types of ACTIVE INGREDIENT in this product: – Benzalkonium chloride and chlorhexidine dihydrochloride are ANTIMICROBIALS. These help 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 CREAM DO NOT USE Dermol Cream if you are ALLERGIC (hypersensitive) to benzalkonium chloride, chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate, or any of the other ingredients of Dermol Cream listed in Section 6. WARNINGS AND P Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dermol Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Liquid paraffin 10.0% w/w Isopropyl myristate 10.0% w/w Benzalkonium chloride 0.1% w/w Chlorhexidine dihydrochloride 0.1% w/w Excipients with known effect: Cetostearyl alcohol For the full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Cream White non-greasy topical emulsion 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS An antimicrobial emollient cream for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The cream is suitable for direct application, and for use as a soap substitute. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For external use only. Before using the 500g pump bottle, turn the top of the pump dispenser anti- clockwise to unlock it. For adults, the elderly, infants and children. _For application to the skin _ Apply Dermol Cream to the affected areas as often as necessary. _For use as a soap substitute _ Dermol Cream may also be used as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel. 4.3 CONTRAINDICATIONS Do not use in cases of known sensitivity (especially generalised allergic reaction) to any of the ingredients (see sections 4.4 and 4.8). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with the eyes. Local skin reactions (e.g. contact dermatitis) to any of the ingredients are rare but possible in sensitive people. There are literature reports of chlorhexidine compounds inducing hypersensitivity, including anaphylactic shock. The prevalence of this is not known, but is likely to be very rare. Dermol Cream should not be administered to anyone with a possible history of allergic reaction to a chlorhexidine compound (see sections 4.3 and 4.8). Dermol Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressing Прочитайте повний документ