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 25^oC.

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