국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorhexidine gluconate
Genus Pharmaceuticals Ltd
D08AC02
Chlorhexidine gluconate
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13110200; GTIN: 5030451004345
PEEL HERE BUT DO NOT REMOVE ECZMOL ™ 250ml 1% W/W CREAM Chlorhexidine Gluconate FOR USE AS A SOAP SUBSTITUTE – use in place of an ordinary soap or shower gel. Ensure the water is warm but not too hot as this can remove your skin’s natural oils. Pat dry with a soft towel after washing. Avoid rubbing too much as this can make dry skin conditions worse. THIS PRODUCT CONTAINS CETOSTEARYL ALCOHOL WHICH MAY CAUSE LOCAL SKIN REACTIONS (E.G. CONTACT DERMATITIS). KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Store below 30°C. ACTIVE INGREDIENT: Chlorhexidine gluconate 1% w/w (incorporated as Chlorhexidine Gluconate Solution 5% v/w). ALSO CONTAINS: cetostearyl alcohol, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, white soft paraffin and water. MA HOLDER: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK PL 06831/0242 92434492002 Read all of this label carefully before you start using this medicine because it contains important information for you. USES: Eczmol is a moisturising and antimicrobial emollient cream, which can also be used as an alternative to soap. It forms a protective barrier on the skin and helps to retain moisture in deeper layers of the skin. This helps to prevent and treat dryness and itching which are common problems for people with eczema and dry skin conditions. The active ingredient, chlorhexidine gluconate, is an antimicrobial which helps combat germs on the skin that make certain types of eczema worse. DIRECTIONS FOR USE: Do not use if tamper evident collar is broken or missing at first use. Prime the pump before first use by depressing fully until cream appears. If the pump stops working do not dismantle the pack. Re-start by covering the nozzle, then fully depress the pump several times to expel air. ECZMOL CREAM IS FOR EXTERNAL USE ON THE SKIN ONLY. Adults, the elderly, infants and children: FOR APPLICATION TO THE SKIN – apply the cream to the affected area and massage into the skin until absorbed. Repeat as often as required. 5 030451 004345 BEFORE YOU 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eczmol 1% w/w Cream Cetraben Protect Antimicrobial 1% Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Gluconate 1% w/w. (incorporated as Chlorhexidine Gluconate Solution 5.0 % v/w) Excipient(s) with known effect Cetostearyl alcohol 2% w/w For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream A white, smooth, pourable cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eczmol/Cetraben Protect Cream is an antimicrobial emollient which can also be used as an alternative to soap in the management of dry and pruritic skin conditions including eczema and dermatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use. For external use only. For adults, the elderly, infants and children FOR APPLICATION TO THE SKIN Apply to the affected areas as often as necessary. FOR USE AS A SOAP SUBSTITUTE Eczmol/Cetraben Protect 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 Known hypersensitivity to the product or any of its components, especially in those with a history of possible Chlorhexidine-related allergic reactions (see section 4.4 and 4.8) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Eczmol/Cetraben Protect Cream contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Eczmol/Cetraben Protect Cream should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8). For topical application only. Keep out of the eyes and ears and avoid contact with the brain and meninges. Hypersensitivity to some of the ingredients of Eczmol/Cetraben Protect Cream may be more common in patients with leg ulcer or stasis dermatitis. Th 전체 문서 읽기