SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

FRADOR

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Chlorbutol BP 1.0 w/v

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

Frador should be applied four times a day, after meals and before going to bed.

Directions:

1.    Dry ulcer with clean tis sue.

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

4.3    Contraindications

Local hypersensitivity to any of the active ingredients is a contra-indication.

1.    Chlorbutol BP

2.    Menthol BP

3.    Prepared Styrax BP

4.    Balsamic Benzoin Vehicle

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    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.

4.9    Overdose

There 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.

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.

Solvent for active ingredients, but having astringent and antiseptic properties.

5.2    Pharmacokinetic properties

Not 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

6.6 Special precautions for disposal

Nothing different.

7    MARKETING AUTHORISATION HOLDER

Castagnola Limited 4J Portman Mansions Chiltern Street London W1M 1LF

8    MARKETING AUTHORISATION NUMBER

PL 1520/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26 November 1992

10 DATE OF REVISION OF THE TEXT

15/07/2015