Thursday, October 20, 2016

Tiger Balm Red





1. Name Of The Medicinal Product



Tiger Balm Red.


2. Qualitative And Quantitative Composition













Ingredient

% w/w

Camphor Ph Eur

11.0% w/w

Menthol Ph Eur

10.0% w/w

Cajuput Oil BPC

7.0% w/w

Clove Oil Ph Eur

5.0% w/w


3. Pharmaceutical Form



Ointment for cutaneous use.



4. Clinical Particulars



4.1 Therapeutic Indications



For the temporary relief of muscular aches and pains.



4.2 Posology And Method Of Administration



To be rubbed gently on the affected parts of the skin as necessary (usually 2 to 3 times daily).



Not to be used on children under 2 years of age.



4.3 Contraindications



Hypersensitivity to any of the ingredients in this product. Do not use on children under two years of age.



4.4 Special Warnings And Precautions For Use



For external use only. Wash hands immediately after use. Do not apply to wounds, damaged or irritated skin. Discontinue use if irritation develops. Avoid contact with the eyes, mucous membranes or other tender areas. Do not bandage tightly. Keep out of the reach of children. If symptoms persist after two weeks, a doctor should be consulted.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Not applicable.



4.6 Pregnancy And Lactation



Avoid excessive use during pregnancy and lactation.



4.7 Effects On Ability To Drive And Use Machines



Not applicable.



4.8 Undesirable Effects



May give rise to hypersensitivity reactions, including contact dermatitis.



4.9 Overdose



Over dosage may result in skin irritation.



Misuse:



Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.



Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma.



Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Menthol and camphor have mild analgesic and rubefacient properties.



Cajuput oil is a mild counter irritant.



Clove oil is rubefacient and slightly analgesic with preservative properties.



5.2 Pharmacokinetic Properties



Camphor and menthol are well absorbed when applied topically, and produce a local effect. The absorption properties of cajuput oil are not known but clove oil appears to be poorly absorbed.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Ingredients



Dementholised Mint Oil



Cinnamon Oil



Yellow Soft Paraffin



Hard Paraffin



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



Tiger Balm has a shelf life of four years.



6.4 Special Precautions For Storage



Do not store above 25oC.



6.5 Nature And Contents Of Container



Glass screw top jar containing 19g Tiger Balm Red, or slip lid tin containing 4 or 8g of Tiger Balm Red.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



LRC Products Ltd



SSL International



Venus



1 Old Park Lane



Trafford Park



Manchester



M41 7HA



England



8. Marketing Authorisation Number(S)



PL 02156/0093.



9. Date Of First Authorisation/Renewal Of The Authorisation



20 August 1996



10. Date Of Revision Of The Text



13/10/2010




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