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FRADOR

Active substance(s): CHLORBUTOL / CHLORBUTOL / CHLORBUTOL

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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.
2.
3.
4.
5.

4.3

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

Contraindications
Local hypersensitivity to any of the active ingredients is a contra-indication.
1.
2.

Chlorbutol BP
Menthol BP

3.
4.

Prepared Styrax BP
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.

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
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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