Summary of medicine characteristics - FRADOR
1 NAME OF THE MEDICINAL PRODUCT
FRADOR
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorbutol BP 1.0 wv
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tincture
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Posology
Frador should be applied four times a day, after meals and before going to bed
Directions:
1. Dry ulcer with clean tissue
2. Dip applicator in Frador Tincture
3. Hold applicator firmly whilst it is in the mouth.
There may be transient smarting
4. Keep mouth open for 30 seconds to allow Frador to dry
5. If healing does not start within a few days consult your doctor
Method of administration
For topical use
4.3 Contraindications
Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
4.4 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.
4.5 Interaction with other medicinal products and other forms of interaction
No known interactions once medication has dried.
4.6 Fertility, pregnancy and lactation
Avoid use in pregnancy.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
In rare occurrences users can experience a local reaction to some or all of the ingredients.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseThere have been no reports of ill-effects from overdosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Menthol: A mild local anaesthetic with pleasant taste and odour, which helps to mask the less pleasant odour of other ingredients
Chlorbutol: Antiseptic and anaesthetic properties
Styrax: 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
Ind. Spirit: Solvent for active ingredients, but having astringent and antiseptic properties
5.2 Pharmacokinetic properties
5.2 Pharmacokinetic propertiesNot applicable.
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carmoisine
Menthol BP
Prep. Styrax BP
Balsamic Benzoin
In alcohol solution to 100%
6.2 Incompatibilities
None.
6.3 Shelf life
3 Years
6.4 Special precautions for storage
1. Storage is at ambient temperature
2. Stock is rotated to avoid build-up of old batches
6.5 Nature and contents of container
Printed Glass Bottle
Closure: Plastic Cap fitted with inert non-porous wad 3.5 ml Frador Tincture