Tuesday, October 25, 2016

Goddards Muscle Lotion





1. Name Of The Medicinal Product



Goddards Muscle Lotion


2. Qualitative And Quantitative Composition












Turpentine Oil

BP

22.0% v/v

Dilute Acetic Acid

BP

30.0% v/v

Dilute Ammonia

BP

14.0% v/v


3. Pharmaceutical Form



Topical Emulsion



4. Clinical Particulars



4.1 Therapeutic Indications



For the symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis, rheumatic pain and pain caused by bruises, sprains, strains, stiff muscles and unbroken chilblains.



4.2 Posology And Method Of Administration



Once or twice daily. Shake the bottle thoroughly. Pour into palm of hand and rub well until dry.



4.3 Contraindications



None known.



4.4 Special Warnings And Precautions For Use



If symptoms persist, consult your doctor.



Do not use if skin is broken.



For external use only.



Keep all medicines out of the reach of children.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



As with all medicines, medical advice should be sought prior to use.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



None known.



4.9 Overdose



Treatment is generally supportive.



Emesis should not be induced.



Lavage should not be performed.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Goddards Muscle Lotion is a traditional rub for the symptomatic relief of muscular pain and stiffness.



5.2 Pharmacokinetic Properties



Not applicable.



5.3 Preclinical Safety Data



Not applicable.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Arlacel 83V



PEG-8-Oleate



Purified Water



6.2 Incompatibilities



None known.



6.3 Shelf Life



22 months unopened.



6.4 Special Precautions For Storage



None.



6.5 Nature And Contents Of Container



Ribbed or non-ribbed, amber or white glass bottle with a plastic cap containing a PVDC/steran faced wad (100 ml or 200 ml).



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Actavis Group PTC ehf



Reykjavíkurvegi 76-78



220 Hafnarfjordur



Iceland.



8. Marketing Authorisation Number(S)



PL 30306/0078



9. Date Of First Authorisation/Renewal Of The Authorisation



10 March 2003



10. Date Of Revision Of The Text



07/0409



11 DOSIMETRY (IF APPLICABLE)


12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)




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