1. Name of the Medicinal Product
Colgate Duraphat Rinse.
2. Qualitative and Quantitative Composition
Active ingredient: sodium fluoride EP 0.2% w/w (900/ppm of fluoride).
For excipients, see 6.1.
3. Pharmaceutical
Mouth wash.
4.1 Therapeutic Indications
As an aid in the prevention of dental caries.
4.2 Posology and Method of Administration
Age 6 years and over.
Once a week, rinse teeth thoroughly for one minute using one or two teaspoonfuls of mouth rinse (5-10ml), then expectorate, do not swallow.
Avoid eating, drinking or rinsing the mouth for 15 minutes afterwards.
Method of administration: for dental use.
4.3 Contra-Indications
Not suitable for children under 6 years of age.
Colgate Duraphat Rinse should not be used in the case of hypersensitivity to any of the ingredients.
4.4 Special Warnings and Precautions for Use
Do not swallow.
This product contains sodium benzoate. Sodium benzoate is a mild irritant to the skin, eyes and mucous membrane.
4.5 Interactions with Other Medicinal Products and Other Forms of Interaction
None known.
4.6 Pregnancy and Lactation
None stated.
4.7 Effects on Ability to Drive and Use Machines
None relevant.
4.8 Undesirable Effects
Hypersensitivity reactions cannot be excluded in rare cases.
Excess dosage may cause nausea and, in children under 12 years of age, dental fluorosis.
4.9 Overdose
See 4.8 Undesirable Effects.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Caries prophylactic agents
ATC code: A01AA01.
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
None stated.
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
Sodium Saccharin
Glycerol
Benzoic Acid
Sodium Benzoate
Pluronic F108
Purified Water
Ethyl Alcohol
Mint Flavour
Blue Colour (E133)
6.2 Incompatibilities
None stated.
6.3 Shelf Life
Four years.
6.4 Special Precautions for Storage
None stated.
6.5 Nature and Contents of Container
150ml high-density polyethylene bottle with polypropylene child-resistant closure.
6.6 Instructions for Use/Handling
None
7.1 Marketing Authorisation Holder
Colgate-Palmolive (UK) Limited
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
8. Marketing Authorisation Number
PL 00049/0019
9. Date of First Authorisation/Renewal of Authorisation
20 January 1977/04 September 1998/16 March 2004
10. Date of (Partial) Revision of the Text
March 2004
11. Legal Classification
P
12. Manufacturer's Recommended Retail Price
£3.59 (150ml bottle)
