Colsor Lotion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colsor Lotion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tannic Acid BP 5.00 % w/w,
Phenol BP 0.50 % w/w,
Menthol BP 0.50 % w/w
3 PHARMACEUTICAL FORM
Topical Solution
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 Colsor lotion sparingly two or three times daily.
4.3 Contraindications
None stated.
4.4 Special warnings and precautions for use
Avoid contact with eyes.
Keep all medicine out of reach of children.
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: |
Used in this product for it’s 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 also effective against certain viruses. |
5.2 Pharmacokinetic properties
Not Applicable.
5.3 Preclinical safety data
Not Applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
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
Amber glass vial containing 10ml.
6.6 Special precautions for disposal
Apply Colsor Lotion sparingly two or three times daily. Avoid contact with the eyes.
MARKETING AUTHORISATION HOLDER
7
Optima Consumer Health Ltd Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 40575/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
3 December 1997
10 DATE OF REVISION OF THE TEXT
31/07/2012