Tiger Balm

Tiger Balm White.

Camphor Ph Eur 11.0% w/w, Menthol Ph Eur 8.0% w/w, Cajuput Oil BPC 13.0% w/w, Clove Oil Ph Eur, 1.5% w/w.

For the full list of excipients, see section 6.1.

Ointment

Tiger Balm White is indicated in adults and children aged 2 years and older:

For the symptomatic relief of minor muscular aches and pains. Do not use on children under 2 years.

Tiger Balm White is indicated in adults only: For the treatment of tension headache.

Posology

Adults and children aged 2 years and older (muscular aches and pains): Adults only (Tension headache)

Method of administration

Muscular aches and pains (Adults and children over 2 years):

To be rubbed gently on the affected parts of skin as necessary (usually 2 to 3 times daily). If symptoms persist after two weeks, a doctor should be consulted (see section 4.4). Do not use on children under two years of age.

Tension headache (Adults only):

Rub the ointment onto the forehead or temples and lightly massage in a circular motion. Use a pea-sized quantity of ointment (approximately 0.5g or less), sufficient to lightly cover the affected area.

Tiger Balm White Ointment should only be applied to the forehead or the temples.

Paediatric population

Do not use in children.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Asthma or other diseases of the respiratory tract that involve hypersensitivity of the airways.

Skin disease, open wounds, inflamed or irritated skin.

Use in infants and children under 2 years, due to the risk of respiratory collapse.

Non tension headache. Non tension headaches include those associated with nausea, vomiting and dizziness; visual disturbance; a unilateral headache; a headache presenting on wakening from sleep and/or following strenuous exercise.

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 apply to the nostrils or inhale. Do not bandage. Keep out of the reach and sight of children.

Muscular aches and pains: if symptoms persist after two weeks, a doctor should be consulted (see section 4.2).

Headache: if symptoms last continuously for 24 hours or recur repeatedly within the next 7 days, medical advice should be sought (see section 4.2).

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Not applicable.

Avoid excessive use during pregnancy and lactation.

Not applicable.

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).

May give rise to hypersensitivity reactions, including contact dermatitis.

Substances containing menthol, camphor or cajuput oil have been reported to cause apnoea, instant collapse or laryngospasm, throat spasms or breathing difficulties in infants and young children following nasal use.

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.

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.

Menthol and camphor have mild analgesic and rubefacient properties. Camphor is also a counter-irritant.

Cajuput oil is a stimulant and mild rubefacient.

Clove oil is counter-irritant and mild analgesic with preservative 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.

None stated.

Dementholised Mint Oil

Yellow Soft Paraffin

Hard Paraffin

Not applicable.

Tiger Balm has a shelf life of four years.

Do not store above 25°C.

Glass screw top jar containing 19g or 30g of Tiger Balm White, or slip lid tin containing 4 or 8g of Tiger Balm White. Not all pack sizes may be marketed.

None stated.

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON,

SW1V 2SA

United Kingdom

PL 02855/0235

Date of first authorisation: 20th August 1996

11/2019