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BENZOIC ACID COMPOUND OINTMENT BP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Benzoic Acid Compound Ointment BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoic Acid BP 6.0% w/w
Salicylic Acid BP 3.0% w/w

3

PHARMACEUTICAL FORM
Ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Topical treatment of localised fungal infections of the skin.

4.2

Posology and method of administration
Topical administration
Adults (including the elderly) and Children
Apply to the affected area 1 to 3 times a day as necessary or as advised by a
doctor.

4.3

Contraindications
Hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use
Should not be applied over mucous membranes, large areas of skin or denuded
skin surfaces. If symptoms persist beyond 10 days, the advice of a doctor
should be sought. Prolonged and excessive use may result in absorption of
sufficient salicylic acid to interact with other drugs such as anticoagulants.

4.5

Interaction with other medicinal products and other forms of interaction
None at recommended doses.

4.6

Fertility, pregnancy and lactation
Safety of use during pregnancy or lactation has not been established and the
use requires careful consideration of benefits versus potential and unknown
risks.

4.7

Effects on ability to drive and use machines
None

4.8

Undesirable effects
Hypersensitivity reactions may rarely occur.

4.9

Overdose
Overdose is unlikely, but in the event of accidental swallowing gastric
irritation, nausea and vomiting may occur. Treatment is symptomatic and
supportive.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The Salicylic Acid and the Benzoic Acid act as antibacterial and antifungal
agent.

5.2

Pharmacokinetic properties
The active ingredients slowly destroy the cells of any fungi or bacteria present.
The epithelium is also slowly and painlessly destroyed.

5.3

Preclinical safety data
None stated

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Emulsifying Wax BP
White Soft Paraffin BP
Liquid Paraffin BP

6.2

Incompatibilities
None stated.

6.3

Shelf life
3 Years.

6.4

Special precautions for storage
None stated.

6.5

Nature and contents of container
Opaque containers and lids

6.6

500g

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0041

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

10

DATE OF REVISION OF THE TEXT

14/09/2011

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