Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Methyl nicotinate; Hydroxyethyl Salicylate ; Methyl salicylate; Ethyl salicylate
The Mentholatum Company Ltd.
M02AC
Methyl nicotinate; Hydroxyethyl Salicylate ; Methyl salicylate; Ethyl salicylate
Unknown
Cutaneous spray, solution
Product not subject to medical prescription
Preparations with salicylic acid derivatives
Marketed
1993-10-18
D1001-5 Manufacturer and MA holder The Mentholatum Co. Ltd. East Kilbride G74 5PE, UK. Last revised May 2017 PA76/3/1 EXTREMELY FLAMMABLE 100g 150 ml 210 FAST RELIEF from rheumatic pain, muscular aches & strains CAUTION: DO NOT USE: • if you are allergic to any of the ingredients • if you are allergic to pain relievers such as aspirin, ibuprofen or other anti-inflammatories • on children under 5 years old • on broken skin, your eyes or other sensitive areas of skin SEE YOUR DOCTOR BEFORE USE: if you are • pregnant • breast feeding • asthmatic • taking medicines that thin the blood (e.g.warfarin), prevent clots (e.g. aspirin) or any other prescribed medicines. STOP USING if excessive irritation, allergic reaction or other unwanted effects occur. Skin burns, blisters and temporary skin redness, rashes or burning sensation may occur. IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR. Some people may experience discomfort, particularly those with sensitive skin or if used in hot weather/after a hot bath. If you get any side effects talk to your doctor. You can also report side effects at www.imb.ie. FOR EXTERNAL USE ONLY. ACTIVE INGREDIENTS: (W/W) Methyl nicotinate 1.6%, 2-Hydroxyethyl salicylate 5.0%, Methyl salicylate 1.0%, Ethyl salicylate 5.0% ALSO CONTAINS: Isopropyl alcohol, Butane KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store below 30°C. Do not use after the expiry (EXP) date shown on the bottom of the can. Ask your pharmacist how to dispose of medicines no longer required. WARNING: Danger. Pressurised container. Do not pierce or burn even after use. Protect from sunlight. Do not expose to temperatures exceeding 50°C/122°F. Keep away from heat/sparks/open flames/hot surfaces - No smoking. Do not spray on an open flame or other ignition source. DEEP HEAT SPRAY is a pain relieving, warming, spray to be used on the skin. It is recommended for the relief of pain in muscles, tendons, joints or bones, lower back and thigh pain, sprains or strains. It can be used before and after exercise. DIRECTIONS FO Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mentholatum Deep Heat Spray, cutaneous spray solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray, solution Clear, colourless solution with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of muscular pain, bursitis and tendinitis, including rheumatic pain, strains, sprains, fibrositis, lumbago and sciatica. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Children over 5 years of age: Spray onto the parts affected when necessary, before or after exercise. Hold spray aperture about 15 centimetres (6 inches) from the skin of the affected area. Spray in 2-3 short bursts up to 3 times per day. Children 5 years of age and under: Not to be used on children under 5 years of age. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not use if you are allergic to any of the ingredients or medicines like aspirin. Consult your doctor before use if you are pregnant, breast-feeding, asthmatic or on any prescribed medicines. For external use only. Not to be sprayed onto broken skin. Avoid inhalation and contact with the eyes and sensitive areas of the skin. Always try on a small area first. Always use sparingly since some people may experience discomfort particularly those with sensitive skin or if used in hot weather or after a bath. Methyl Nicotinate 1.60 %w/w 2-Hydroxyethyl Salicylate 5.00 %w/w Methyl Salicylate 1.00 %w/w Ethyl Salicylate 5.00 %w/w H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lesen Sie das vollständige Dokument