Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MENTHOL CAMPHOR METHYL SALICYLATE CAPSAICIN
William Ransom & Son Plc
2.54%w/w,1 %v/v
Cream
1998-03-20
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Radian B Muscle Rub Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream Smooth, homogenous off-white cream with characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of aches and pains including, muscular stiffness, bruising, sprains and fibrositis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external application. Adults and Children over 6 years. 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. Children under 6 years: Not recommended. Elderly: The adult dose is appropriate. 4.3 CONTRAINDICATIONS Not to be used on children under 6 years old. Do not apply to skin abrasions. Do not apply to irritated skin. Active ingredients %w/w Levomenthol 2.54 Total camphor as 1.43 Racemic camphor 1.41 Camphor Oil, White 0.32 Methyl salicylate 0.42 Capsicum oleoresin 0.005 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/07/2006_ _CRN 2025600_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Keep away from eyes and sensitive areas. If symptoms persist, consult a doctor. Use sparingly on tender skin and do not cover immediately after application. If an adverse reaction occurs, discontinue use immediately. 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. 4.6 PREGNANCY AND LACTATION There is no, or inadequate evidence of safety in human pregnancy. Use in pregnancy only when there is no safer alternative. Use in lactation is ac Read the complete document