SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Compound Benzoic Acid Ointment BP Whitfield's Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzoic Acid BP    6%

Salicylic Acid BP    3%

3 PHARMACEUTICAL FORM

Ointment

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of Tinea and other fungal infections of the skin.

4.2 Posology and method of administration

Adults, children and the elderly:

Apply externally.

Twice daily or in accordance with directions of an appropriate practitioner.

4.3 Contraindications

Hypersensitivity to benzoic acid or salicylic acid.

4.4 Special warnings and precautions for use

Use with caution on large areas of skin.

Allergic reactions to benzoic acid and salicylate have been reported. If the patient is affected the physician should be contacted.

It is a topical preparation and should not be ingested.

Keep away from eyes and mucous membranes.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Should be avoided in first 3 months of pregnancy.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

None known.

4.9 Overdose

Accidental ingestion of this product may cause gastric irritation. Treatment consists of supportive measures and symptomatic measures, including gastric lavage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

N/A.

5.2 Pharmacokinetic properties

N/A.

5.3 Preclinical safety data

None available specific to this product.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White Soft Paraffin BP

Emulsifying Wax Anionic BP Liquid Paraffin BP

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months in unopened container.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Polypropylene container with polyethylene wadless tamper evident closure holding 500gm. or 25gm and 50gm in amber glass jar with plastic wadded screw cap.

Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside

PR9 9AL

8    MARKETING AUTHORISATION NUMBER(S)

PL 03105/0048

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

06/07/1993 / 28/11/2003

10 DATE OF REVISION OF THE TEXT

28/11/2003