Friars Balsam BP

Tincture

4.1 Therapeutic indications

1. As an inhalant for relief of the symptoms of colds.
2. As a mild antiseptic dressing.4.2 Posology and method of administration
3. Through the mouth and nasal passages.
4. Topical.
5. **As an inhalant** Adults, children over 3 months of age and the elderly: add one 5ml spoonful to a pint of hot, but not boding water. The dose may be repeated after 4 hours if required. The product is suitable for use under this clinical indication by adults, children over 3 months and the elderly. Not suitable for children under 3 months of age.
6. **As an antiseptic** Adults, children and the elderly: apply undiluted to the affected area twice daily. The product is suitable for use under this clinical indication by adults, children and the elderly.4.3 Contraindications Contraindicated in patients with known sensitivity to sumatra benzoin or storax.4.4 Special warnings and precautions for use Not suitable for children under 3 months when used as an inhalant. For external use only. Keep all medicines away from children. Caution: Highly flammable. Keep away from a naked flame.4.5 Interaction with other medicinal products and other forms of interaction None known.4.6 Pregnancy and lactation Use of this product by the indicated routes is not considered likely to cause any undesirable effects in the above conditions.4.7 Effects on ability to drive and use machines None known.4.8 Undesirable effects Allergic 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/yellowcard4.9 Overdose This product is for external use only. Accidental ingestion is likely to cause a severe burning sensation in the mouth and mucous membranes due to the high alcohol content and the bitter taste of the aloes and balsamic acids. Dilution of the product in the mouth will cause the separation of an unpleasant gummy residue. It is considered unlikely that a significant quantity could be swallowed. However the main effects would be those of alcohol intoxication.

5.1 Pharmacodynamic properties Sumatra benzoin has been used as an ingredient in inhalations used in the treatment of catarrh of the upper respiratory tract for many years. It has also been used topically for its antiseptic and protective properties. Storax has mild antiseptic action.5.2 Pharmacokinetic properties No information available.5.3 Preclinical safety data None.

6.1 List of excipients Aloes powdered BP, Purified water BP, Ethanol (96%) BP.6.2 Incompatibilities None known.6.3 Shelf life 36 months unopened.6.4 Special precautions for storage Store below 25°C.6.5 Nature and contents of container 50ml Glass bottle with a 28mm polypropylene cap with tamper evident band and EPE/Saranex Liner.6.6 Special precautions for disposal and other handling None.