国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ethyl nicotinate; Methyl nicotinate; Benzyl nicotinate; Hydroxyethyl salicylate; Capsicum oleoresin
Norma Chemicals Ltd
n/a
Ethyl nicotinate; Methyl nicotinate; Benzyl nicotinate; Hydroxyethyl salicylate; Capsicum oleoresin
10mg/1gram ; 10mg/1gram ; 10mg/1gram ; 20mg/1gram ; 100microgram/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 10030200
Dulbalm Cream _Please read this leaflet carefully before using this _ _medicine. If you have any questions or are not sure _ _about anything, ask your doctor or pharmacist. _ WHAT DOES THE CREAM CONTAIN? Each 100g of cream contains Ethyl Nicotinate 1g, Methyl Nicotinate BP 1g, Benzyl Nicotinate 1g, Glycol Salicylate 2g and Capsicum Oleoresin BPC 10mg. In addition to the active ingredients the cream also contains Emulsifying Wax, White Soft Paraffin, Polysorbate 80, Cineole and Purified Water. WHAT PACK SIZES ARE AVAILABLE? Dulbalm Cream is available in 25g tubes. HOW DOES THE CREAM WORK? Dulbalm Cream is a topical analgesic cream. The active ingredients exert a rubifacient (warming) action on the skin. WHO IS RESPONSIBLE FOR PLACING THE CREAM ON THE MARKET? The product licence holder is Norma Chemicals Ltd 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF, United Kingdom Product licence number: PL 00386/5007R WHO MANUFACTURES THE CREAM? The cream is manufactured by: - Thorpe Laboratories Ltd., Enterprise Road, Mablethorpe, Lincs. LN12 1NB WHAT IS THE CREAM FOR? The symptomatic relief of the pain and stiffness associated with muscular rheumatism, lumbago, sciatica, fibrositis, sprains and chilblains. WHAT SHOULD I KNOW BEFORE I USE THE CREAM? Dulbalm Cream is for external use only. Do not apply to broken or tender skin. Keep away from eyes. Do not use the cream if you know or suspect that you are hypersensitive or allergic to any of the ingredients. Wash hands after use. Do not apply to children under 6 years of age. If you are pregnant or breast feeding, consult your doctor or pharmacist before using this cream as it is generally best not to use medicines at this time. HOW DO I USE THE CREAM? Do not apply near to eyes, nose, mouth, anal and urinary areas. Discontinue use if a rash develops. Do not cover the treated area with dressings that prevent the passage of air and/or water. Do not expose treated areas to excessive amounts of sunlight. WHAT IS THE DOSE? Apply with gentle massage 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dulbalm Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ethyl Nicotinate 1% Methyl Nicotinate BP 1% Benzyl Nicotinate 1% Glycol Salicylate 2% Oleoresin Capsicum BPC 1973 0.01% 3. PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS External application for the symptomatic treatment of muscle stiffness, muscular rheumatism, lumbago, sciatica, fibrositis, sprains and chilblains. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Apply externally with gentle massage 2 - 3 times daily, avoiding broken or inflamed skin. DO NOT APPLY TO CHILDREN UNDER 6 YEARS OF AGE. 4.3. CONTRA-INDICATIONS Known sensitivity to any of the ingredients. Do not apply to children less than six years old. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not apply to broken or tender skin. Application on mucous membranes should be avoided. Discontinue if rash develops. Not for use with occlusive dressings. Topical application may result in systemic effects, including asthma. Patients should be advised against excessive exposure of areas treated to sunlight, in order to avoid possibility of photosensitivity. Keep away from eyes. Wash hands after use. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6. PREGNANCY AND LACTATION As with most medicines, use in pregnancy or breastfeeding should be avoided. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8. UNDESIRABLE EFFECTS Photosensitivity and application site reactions. 4.9. OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES All the active ingredients in Dulbalm Cream are topical vasodilators with rubifacient activity. 5.2. PHARMACOKINETIC PROPERTIES External application of Dulbalm Cream to intact skin results in negligible systemic absorption. 5.3. PRECLINICAL SAFETY DATA Not applicable. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Emulsifying Wax, White Soft Paraffin, Polysorbate 80, Cineole, Purified Wate 完全なドキュメントを読む