Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Potassium hydroxyquinoline sulfate; Chlorocresol
Optima Consumer Health Ltd
n/a
Potassium hydroxyquinoline sulfate; Chlorocresol
2mg/1gram ; 2mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100101
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING CARTON – COLLAPSIBLE ALUMINIUM TUBE 1. NAME OF THE MEDICINAL PRODUCT Valderma Cream Potassium Hydroxyquinoline Sulphate, Chlorocresol 2. STATEMENT OF ACTIVE SUBSTANCE(S) Potassium Hydroxyquinoline Sulphate 0.2 %w/w Chlorocresol 0.2 %w/w 3. LIST OF EXCIPIENTS Hard paraffin Stearic acid Technical white oil Cetostearyl alcohol Cetyl ester wax Urea Sodium lauryl sulphate Sodium hydroxide Geraniol Purified water 4. PHARMACEUTICAL FORM AND CONTENTS Cream 15g 30g 45g 60g 5. METHOD AND ROUTE(S) OF ADMINISTRATION Topical use. Read this carton before use. Do not discard this carton as it contains important information for Valderma Cream. For external use only. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY Do not 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 build up but not totally remove it. FIRE HAZARD. DO NOT SMOKE OR GO NEAR NAKED FLAMES; CLOTHING & BEDDING WITH THIS PRODUCT DRIED ON THEM CAN CATCH FIRE EASILY. 8. EXPIRY DATE EXP (MM/YYYY) 9. SPECIAL STORAGE CONDITIONS Do not store above 25°C. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused medicinal product should be disposed of in accordance with local requirements. 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Optima Consumer Health Limited Concept House Brackenbeck Road Bradford BD7 2LW UK 12. MARKETING AUTHORISATION NUMBER(S) PL 40575/0009 13. BATCH NUMBER<, DONATION AND PRODUCT CODES> _ _ BN: 14. GENERAL CLASSIFICATION FOR SUPPLY _ _ P 15. INSTRUCTIONS ON USE Valderma is an antibacterial cream. It is used for the treatment of common skin complaints such as spots Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valderma Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION % w/w Potassium Hydroxyquinoline Sulphate 0.2 Chlorocresol 0.2 (equivalent to 0.125% w/w of 8-hydroxyquinoline base) Excipients with known effects Cetostearyl alcohol Sodium Lauryl Sulphate For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of all common minor skin troubles, for example spots and pimples. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and Children: Wash the affected area with warm water and a gentle soap. Rub in the cream. There is no indication that dosage need be modified for the elderly. The product may be applied freely two or three times a day to the affected area of the skin. Method of administration Topical 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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. Treatment should be terminated if irritation develops. In the event of any irritation of sensitive skin, wash with luke-warm water. Product labelling If symptoms persist, consult your doctor. Keep out of the sight and reach of children. For external use only. This medicine contains cetostearyl alcohol which may cause local skin reactios (e.g. contact dermatitis) This medicine contains sodium lauryl sulphate. Sodium lauryl sulphate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area. The thickness of the skin varies considerably according to the body site and with age and can be an important factor in the sensitiv Izlasiet visu dokumentu