This information is intended for use by health professionals

1. Name of the medicinal product

Tiger Balm Red.

2. Qualitative and quantitative composition

Ingredient

Camphor Ph Eur

Menthol Ph Eur

Cajuput Oil BPC

Clove Oil Ph Eur

% w/w

11.0% w/w

10.0% w/w

7.0% w/w

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 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 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

Adverse reactions reported from extensive post-marketing experience are tabulated below by System Organ Class and frequency. The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Body System

Undesirable effect

Frequency

General disorders and administration site conditions

Burn at application site

Not known

May give rise to hypersensitivity reactions, including contact dermatitis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

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°C.

6.5 Nature and contents of container

Glass screw top jar containing 19g or 30g of 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

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

PL 02855/0234

9. Date of first authorisation/renewal of the authorisation

20th August 1996

10. Date of revision of the text

21st August 2018