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COLSOR CREAM

Active substance(s): MENTHOL / PHENOL / TANNIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Colsor Cream
Solpel Cold Sore Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Tannic Acid BP
Phenol BP
Menthol BP

3

5.00 % w/w
1.00% w/w
0.50 % w/w

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
Water
Emulsifying Wax BP
Cetostearyl Alcohol BP
IMS BP

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.

7

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
28th November 1991

10

DATE OF REVISION OF THE TEXT
31/07/2012

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Further information

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