SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Colsor Cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Tannic Acid BP	5.00 % w/w
Phenol BP	1.00% w/w
Menthol BP	0.50 % w/w

3    PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of symptoms of cold sores and sun-blistered lips.

4.2    Posology and method of administration

Apply as necessary up to 6 times a day and always at bedtime.

4.3    Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

For external use only.

Avoid contact with eyes.

Keep out of reach of children.

If undesirable/unexpected adverse effects occur consult your doctor or pharmacist.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, Pregnancy and lactation

None stated.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None stated.

4.9 Overdose

Not applicable

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Tannic Acid BP is used for its astringent properties.

Menthol BP relieves itching. It also causes a sensation of coldness, followed by an analgesic effect.

Phenol BP is a disinfectant, effective against gram-positive and gram-negative bacteria. It is active against certain viruses.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

6.2 Incompatibilities

None stated

6.3 Shelf life

36 months

6.4 Special precautions for storage

Dry, frost free below 25°C

6.5 Nature and contents of container

Aluminium tube 5g.

6.6 Special precautions for disposal

Use up to 6 times a day and always at bedtime.

MARKETING AUTHORISATION HOLDER

Optima Consumer Health Ltd Concept house,

Brackenbeck Road,

Bradford,

BD7 2LW,

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 40575/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28^th November 1991

10    DATE OF REVISION OF THE TEXT

31/07/2012