البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CAMPHOR; CAPSICUM OLEORESIN; MENTHOL; METHYL SALICYLATE
DEVRIES & CO. LTD
M02AC
CREAM
MENTHOL 2.54 %W/W; CAMPHOR 1.43 %W/W; CAPSICUM OLEORESIN 0.005 %W/W; METHYL SALICYLATE 0.42 %W/W
TOPICAL
Not required
THORNTON & ROSS LTD, UK
PREPARATIONS WITH SALICYLIC ACID DERIVATIVES
Relief of rheumatic pains and mild muscle pains.
2022-06-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is supplied without physician’s prescription RADIAN ® B MUSCLE RUB Cream ACTIVE INGREDIENTS: Menthol 2.54% Camphor 1.43% Methyl salicylate 0.42% Capsicum oleoresin 0.005% Inactive ingredients and allergens: See under “_Important information about _ _some of the medicine’s ingredients_” in section 2 and section 6 “_Additional _ _information_”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your physician or pharmacist. Use this product according to the instructions in the section about dose in this leaflet. Consult the pharmacist if you need further information. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is indicated for relief of rheumatic pain and mild muscle pain. THERAPEUTIC GROUP: methyl salicylate which belongs to the salicylate group. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE: • If you are sensitive (allergic) to the active ingredients or to any of the other ingredients that this medicine contains. • If you are allergic to salicylates (e.g. aspirin), or to any other non- steroidal anti-inflammatory drug. • On open wounds, irritated skin, face, eyes and sensitive areas. • In children under the age of 6 years. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE • Do not allow contact of the product with the eyes. In case of contact, rinse with water immediately. • Avoid contact of the product with mucosal tissue (such as the mouth and the nose). • Do not light a cigarette or go near open flames: there is a risk of severe burns. Fabric (clothing, bed and table linen, etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Laundering the clothing and linen may reduce product residues but will not necessarily remove them completely. CHILDREN AND ADOLESCENTS Do not use in children under 6 years old. RAD اقرأ الوثيقة كاملة
1 NAME OF THE MEDICINAL PRODUCT Radian B Muscle Rub 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Menthol 2.54% w/w Camphor 1.41% w/w Methyl Salicylate 0.42% w/w Camphor Oil, White 0.32%w/w Oleoresin Capsicum 0.005% w/w Camphor and Camphor Oil, White are collectively declared as: Camphor Excipient(s) with known effect Emulsifying Wax (containing Sodium laurilsulfate and Cetostearyl alcohol) For the full list of excipients, see section 6.1. 1.43% w/w 9.70% 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of rheumatic pains and mild muscle pains . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external use application Adults and children over 6 Apply to the affected parts and slowly massage well into the skin. For muscular strains and stiffness it is best used after a hot bath. Repeat application up to three times daily, reducing to morning and evening when acute symptoms subside. Elderly The adult dose is appropriate. Children Do not use on children under 6 years old. 4.3 CONTRAINDICATIONS Hypersensitivity to salicylates, to other active substances or to any of the excipients listed in section 6.1. If irritation develops, use of the product should be discontinued. Not to be used on children under 6 years old. Do not apply to skin abrasions. Do not apply to irritated skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Keep away from eyes and sensitive areas. If symptoms persist consult a doctor. Wash hands thoroughly after use. The excipients cetostearyl alcohol, lanolin and 0.91% w/w sodium laurilsulfate may cause local skin reactions (e.g. contact dermatitis, stinging or burning sensations) or increased skin reactions caused by other products when applied to the same area. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin. Menthol has also been reported to interact with warfarin (when taken orally), decreasing its effectiveness. 4.6 FERTILITY, PRE اقرأ الوثيقة كاملة