1. Name of the Medicinal Product
FluoriGard Daily Mouth Rinse.
2. Qualitative and Quantitative Composition
Active Ingredient
Sodium fluoride Ph Eur 0.05% w/w (225 ppm F).
3. Pharmaceutical Form
Rinse
Route of Administration: Oral
4.1 Therapeutic Indications
To aid in protection against dental caries.
4.2 Posology and Method of Administration
Dosage:
-
Age 6 years and over
-
Use once per day, preferably after brushing teeth
-
Rinse 5-10ml around and between teeth for one minute and then spit out
-
Do not eat, drink or rinse mouth for at least 15 minutes afterwards
4.3 Contraindications
Do not use under 6 years of age.
4.4 Special Warnings and Special Precautions for Use
-
Do not swallow
-
Excess dosage may cause nausea, and in children under seven, dental fluorosis
-
Keep medicines out of reach of children
4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
None stated.
4.6 Pregnancy and Lactation
None stated.
4.7 Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable Effects
None.
5. Pharmacological Properties
Colgate FluoriGard Daily Mouth Rinse is a fluoride dental mouth rinse that is topically administered to human beings in a dental caries prevention programme and is a pleasant-tasting clear-blue minty liquid.
5.1 Pharmacodynamic Properties
Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralisation and by inhibiting the cariogenic microbial process.
5.2 Pharmacokinetic Properties
Fluoride is absorbed locally by the teeth. When swallowed, fluoride is absorbed rapidly and extensively (90-100 percent). Peak fluoride plasma levels are achieved within 30 to 60 minutes. Fluoride is widely distributed through the body and concentrates in the bone and tooth. About 50 percent of the intake is stored. Excretion is primarily through the kidneys with less than 10 percent being excreted in the faeces and less than 1 percent in sweat and saliva.
5.3 Preclinical Safety Data
Not applicable, since fluoride has been used in man for many years and its effects are well known.
6. Pharmaceutical Particulars
6.1 List of Excipients
Ethyl Alcohol BP
Pluronic F-108
Glycerol Ph Eur
Saccharin Sodium Ph Eur
Sodium Benzoate Ph Eur
Benzoic Acid Ph Eur
Food Blue No. 5 (E131)
Flavour
Purified Water Ph Eur
6.2 Incompatibilities
None.
6.3 Shelf Life
Four years.
6.4 Special Precautions for Storage
None.
6.5 Nature and Contents of Container
300ml and 500ml clear polyethylene terephthalate, flat bottles with a white polypropylene screw cap, child resistant and tamper evident. A round 50ml bottle is available as a sample; this bottle is made of the same materials as the 300ml and 500ml bottles.
6.6 Instructions for Use
None stated.
7. Marketing Authorisation Holder
Colgate-Palmolive (UK) Limited
Guildford Business Park
Middleton Road
Guildford
Surrey
GU2 8JZ
8. Marketing Authorisation Number
PL 00049/0012
9. Date of First Authorisation/Renewal of Authorisation
12 February 1976 / 10 September 2003
10. Date of (Partial) Revision of the Text
September 2003
11. Legal Classification
GSL
12. Manufacturers Recommended Retail Price
£4.35 (500ml bottle)
