1. Trade Name of the Medicinal Product
Colgate Fluorigard Gel-Kam
2. Qualitative and Quantitative Composition
Stannous Fluoride 0.4% w/w
3. Pharmaceutical Form
Oral gel
4.1 Therapeutic Indications
As an aid in the treatment and prevention of dental caries and decalcification of the teeth.
Colgate Fluorigard Gel-Kam gel will prevent caries, decalcification and demineralisation of the teeth when used on a daily basis.
Colgate Fluorigard Gel-Kam will also treat and arrest active surface caries in enamel and dentine preventing further carious breakdown of the dentition.
4.2 Posology and Method of Administration
Recommended for adults and children over 3 years old. The dosage for children, adults and the elderly is the same.
Apply Colgate Fluorigard Gel-Kam to a clean toothbrush, as you would a toothpaste, once a day at bedtime or as part of the last regular tooth brushing regime before going to bed. Brush Colgate Fluorigard Gel-Kam on to all the tooth surfaces; swish around for one minute, similar to a rinse, pushing the gel between the teeth with the tongue and cheek muscles, then spit out the excess. Do not swallow or rinse out.
Route of administration: application to the teeth and gingivae of human beings.
4.3 Contra-indications
Known allergies to fluoride.
4.4 Special Warnings and Precautions for Use
Do not swallow the excess gel.
Do not use on children under 3 years as they are incapable of spitting out excess. Do not use more than the recommended dose.
Keep out of the reach of children.
Close bottle after use.
Do not add water.
4.5 Interactions with Other Medicaments and Other Forms of Interaction
No known interactions.
4.6 Pregnancy and Lactation
Colgate Fluorigard Gel-Kam can be used during pregnancy and lactation.
4.7 Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable Effects
Colgate Fluorigard Gel-Kam will not stain intact enamel but there may be superficial light brown pigmentation of plaque if the teeth are not cleaned properly. This is easily removed by professional scaling and prophylaxis. It may be minimised by the use of a conventional toothpaste prior to using Colgate Fluorigard Gel-Kam.
4.9 Overdose
Not applicable; none reported. The use of this type of product is not expected to result in an overdose.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
0.4% Stannous Fluoride prevents and treats dental caries and decalcification by increasing the resistance of the enamel and root surfaces of the teeth to acid attack. Of the fluorides available for topical application, stannous fluoride has proved to be the fluoride of choice due to the fact that the stannous ion combines with the naturally occurring phosphate in the enamel to form stannous fluorophosphate which serves as a protective coating to the tooth.
5.2 Pharmacokinetic Properties
0.4% stannous fluoride should be used daily for the most efficacious results. Studies have shown that if it is not used daily then the incidence of caries may increase. When used daily, 0.16mg of fluoride ion may be ingested when the excess is expectorated. Should the total dosage on a standard toothbrush be swallowed then 1.08mg of fluoride may be ingested. Practitioners should be aware of the total daily dose of fluoride ion from all sources including toothpaste.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List of Excipients
Glycerin USP, Hydroxyethylcellulose NF.
Added flavours: Containing
Mint: Creme de Menthe flavour F-1328
Mixed Fruit: Black Cherry No. 33.314, Raspberry No. 125.279 and Strawberry No. 133.275
Cinnamon: Creme de Menthe F-1328, Cinnamon Oil
Grape: Grape No. 61.6202
6.2 Incompatibilities
None.
6.3 Shelf Life
Three years.
6.4 Special Precautions for Storage
Do not store above 25°C
6.5 Nature and Contents of Container
(a) 100ml or 50ml bottles of white LDPE fitted with a polyethylene closure which is flip top and child resistant.
(b) A laminate web tube with a moulded polypropylene closure and tamper evident seal. Each tube contains 100ml.
6.6 Instructions for Use/Handling
None.
7.1 Marketing Authorisation Holder
Colgate-Palmolive (UK) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey
GU2 8JZ
8. Marketing Authorisation Number
PL 00049/0028
9. Date of First Authorisation/Renewal of Authorisation
1 June 1992/12 June 2001
10. Date of (Partial) Revision of the Text
June 2001
11. Legal Classification
P
12. Manufacturer's Recommended Retail Price
£4.19 (100ml tube)
