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1. Name Of The Medicinal Product
Benzoin Tincture Compound BP or Friars Balsam BP
2. Qualitative And Quantitative Composition
Storax prepared BP 10.0% w/v
Benzoin sumatra crushed BP 10.0% w/v
3. Pharmaceutical Form
Tincture
4. Clinical Particulars
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
1. Through the mouth and nasal passages.
2. Topical.
1. As an inhalant
Adults, children over 3 months of age and the elderly: Add one 5ml spoonful to a pint of hot, but not boiling 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.
2. 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
None known.
4.9 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. Pharmacological Properties
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. Pharmaceutical Particulars
6.1 List Of Excipients
Aloes powdered BP, purified water BP, ethanol (96%) BP
6.2 Incompatibilities
None known.
6.3 Shelf Life
25ml: 36 months unopened.
50ml: 36 months unopened.
500ml: 36 months unopened.
2000ml: 36 months unopened.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
25ml:
glass bottle and plastic cap with liner.
50ml:
glass bottle and plastic cap with liner or white 28mm polypropylene cap with Tamper Evident band and EPE/Saranex liner.
500ml:
glass bottle and plastic cap with liner.
2000ml:
glass bottle and plastic cap with liner.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
L.C.M. Ltd.,
Linthwaite Laboratories
Huddersfield
HD7 5QH
England
8. Marketing Authorisation Number(S)
PL 12965/0002
9. Date Of First Authorisation/Renewal Of The Authorisation
11/10/93 19/11/98
10. Date Of Revision Of The Text
March 2005
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
Friars Balsam BP
.
