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COMPOUND BENZOIN TINCTURE B.P.

Active substance(s): ALOES / PREPARED STORAX / SUMATRA BENZOIN GROUND

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1.

NAME OF THE MEDICINAL PRODUCT
Compound Benzoin Tincture BP or Friars’ Balsam BP.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoin (Ground) 10.0 % w/v
Prepared Storax 10.0% w/v
Aloes 2.0% w/v.

3.

PHARMACEUTICAL FORM
Concentrate for inhalation solution.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the relief of colds and laryngitis.

4.2.

Posology and method of administration
Adults the elderly and children over 3 months
Add one 5 ml spoonful to a pint of hot, but not boiling, water and inhale the vapour.
Children under 3 months
Not recommended for children under 3 months.
Route of administration
Inhalation of the vapours released by the addition of the product to hot water.

4.3.

Contraindications
Apart from the possibility of skin sensitisation (See 4.8 below) in a few persons using
the product, no other contraindications have been reported.

4.4.

Special warnings and precautions for use
If symptoms persist consult your doctor.

4.5.

Interactions with other medicinal products and other forms of interaction
No significant interactions have been reported.

4.6.

Pregnancy and lactation
No significant problems have been reported either with pregnant women or with nursing
mothers who are breast feeding; However, as with many other medicines, its use, especially
in the first three months of pregnancy, is recommended only when the benefits outweigh any
risks.

4.7.

Effects on ability to drive and use machines
None known.

4.8.

Undesirable effects
Skin sensitisation has been reported.

4.9.

Overdose
Overdosage is unlikely to present a significant risk but if it does occur then the treatment
consists of general supportive therapy and may include gastric lavage.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Benzoin
It is reported to have expectorant properties in the relief of catarrh and congestion of the
upper respiratory tract.
Storax (Prepared)
It is reported to have a similar action to Benzoin in the relief of catarrh and congestion of the
upper respiratory tract.
Aloes
It is uncertain what pharmacological action it plays when used in Compound Benzoin
Tincture B.P. as a treatment for the relief of catarrh and congestion of the upper respiratory
tract.

5.2.

Pharmacokinetic properties

Benzoin / Storax (Prepared) / Aloes
Little information is available in the literature regarding the pharmacokinetic
particulars of these three compounds when administered by nasal inhalation of the
vapours released when the product is added to hot water.

5.3.

Preclinical safety data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Ethanol 96%
Potable water.

6.2.

Incompatibilities
No significant major incompatibilities have been reported other than the fact that solid
material is precipitated on addition of water.

6.3.

Shelf life
60 months.

6.4.

Special precautions for storage
Do not store above 25°C.

6.5.

Nature and contents of container
Dispensing packs
2000 ml HDPE bottle with plastic screw cap with an aluminium foil lined EPE liner.
500 ml HDPE bottle with a wadless polypropylene cap.
OTC Packs
50 ml and 100 ml amber glass bottles with a plastic Jay cap closure.
Not all pack sizes may be marketed.

6.6.

Instruction for use and handling, (and disposal)
None.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0038

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
14th April 2005

10.

DATE OF (PARTIAL) REVISION OF THE TEXT

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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