Active substance(s): CHLORBUTOL
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorbutol BP 1.0 w/v
The clinical indications for this product are recurrent aphthous ulcers, buccal
herpes simplex lesions and local gum ulcers.
Administration is topical to the buccal mucosa.
Posology and method of administration
Frador should be applied four times a day, after meals and before going to bed.
Dry ulcer with clean tissue.
Dip applicator in Frador Tincture.
Hold applicator firmly whilst it is in the mouth.
There may be transient smarting.
Keep mouth open for 30 seconds to allow Frador to dry.
If healing does not start within a few days consult your doctor
Local hypersensitivity to any of the active ingredients is a contra-indication.
Prepared Styrax BP
Balsamic Benzoin Vehicle
Special warnings and precautions for use
Keep out of reach of children.
For adult use only.
Not to be taken internally.
Keep away from naked flame.
Interaction with other medicinal products and other forms of interaction
No known interactions once medication has dried.
Pregnancy and lactation
Avoid use in pregnancy.
Effects on ability to drive and use machines
In rare occurrences users can experience a local reaction to some or all of the
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
There have been no reports of ill-effects from overdosage.
A mild local anaesthetic with pleasant taste and odour, which
helps to mask the less pleasant odour of other ingredients.
Antiseptic and anaesthetic properties.
Soothing properties and helps to retain other ingredients in
location of the affected area after the solvent has evaporated.
Gum Benzoin: Forms protective coating over the affected area and retains
other ingredients at the point of application.
Solvent for active ingredients, but having astringent and
Preclinical safety data
List of excipients
Prep. Styrax BP
In alcohol solution to 100%
Special precautions for storage
Storage is at ambient temperature
Stock is rotated to avoid build-up of old batches
Nature and contents of container
Printed Glass Bottle
Closure: Plastic Cap fitted with inert non-porous wad 3.5 ml Frador Tincture
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
4J Portman Mansions
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
26 November 1992
DATE OF REVISION OF THE TEXT