Colgate® Duraphat® Varnish

1. COMPOSITION

1mL suspension contains 50mg sodium fluoride (5%w/v), equivalent to 22,600ppm fluoride ion, [22.6mg fluoride] in an alcoholic solution of natural resins.

2. INDICATIONS

Caries prevention by deep penetration with fluoride. Desensitisation of sensitive teeth.

3. METHOD OF APPLICATION

Colgate Duraphat varnish is to be applied by the dentist, and is not for self-medication by the patient. Before applying Colgate Duraphat, excess plaque should be removed and the teeth dried. Colgate Duraphat is applied as a thin layer to the most affected areas of dentition using a brush, probe or applicator.

4. DOSAGE

For primary teeth up to 0.25mL (5.65mg fluoride). 

For mixed dentition up to 0.40mL (9.04mg fluoride). 

For permanent dentition up to 0.75mL (16.95mg fluoride). 

For caries prevention, the application is usually repeated every 6 months but more frequent applications (every 3 months) may be made. For hypersensitivity 2 or 3 applications should be made within a few days. The patient should not brush the teeth or chew food for 4 hours after treatment.

5. CONTRAINDICATIONS

Hypersensitivity to colophony (natural resin), ulcerative gingivitis, stomatitis, and bronchial asthma.

6. PRECAUTIONS

Colgate Duraphat is indicated as a spot application fluoride treatment for at risk tooth surfaces and should not be applied to the whole dentition in one session. Not for systemic treatment. DO NOT SWALLOW. As this product contains 33.8% volume of ethanol, it is recommended to avoid its use in pregnant or lactating women. Each dose contains up to 0.2g of alcohol.

7. INTERACTION WITH OTHER DRUGS

On the day when Colgate Duraphat has been applied, no high dose fluoride preparations such as fluoride gels should be used. The administration of fluoride supplements should be suspended for several days after applying Colgate Duraphat. The presence of alcohol in the Duraphat formula should be considered.

8. ADVERSE REACTIONS

In subjects with a tendency to allergic reactions, oedematous swelling of the oral mucosa has been observed in exceptional cases, especially after extensive application. Ulcerative gingivitis and stomatitis have been reported by sensitive individuals. In rare cases, asthma attacks may occur in patients who have bronchial asthma. In patients with gastric sensitivity retching or vomiting may occur after a high dosage and extensive application. If necessary the varnish layer can easily be removed from the mouth by brushing and rinsing.

9. INSTRUCTIONS FOR USE

• Colgate Duraphat should preferably be applied to those spots most susceptible to caries attack.
• Prophylaxis is only required if thick plaque deposits are present.
• Teeth should be isolated and gently dried.
• Duraphat can be applied using a brush, probe or applicator.
• The yellowish colour of Colgate Duraphat greatly facilitates its application and control. Colgate Duraphat sets in the presence of saliva. The effect of Colgate Duraphat is dependant on the prolonged activity of fluoride. The varnish film should not be removed prematurely. Patients should be advised not to brush their teeth or chew food for at least 4 hours after treatment. During this time fluids and soft foods may be consumed.
• Instruments, clothing etc which comes into contact with Colgate Duraphat can be cleaned with alcohol.

10. OVERDOSAGE

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting and diarrhea may soon occur after ingestion (within 30 minutes) and are accompanied by salivation, heamaternesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight have been ingested give calcium (eg milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight has been ingested give milk orally if possible and seek immediate medical assistance. For accidental ingestion of more than 15mg fluoride/kg body weight, admit immediately to a hospital facility. For further information, contact the Poisons Information Centre on 13 1126 (Australia), 0800 764 766 (New Zealand).

11. EXCIPIENT INGREDIENTS

Ethanol, white beeswax, shellac, colophony BP, mastic, sodium saccharin, flavour.

12. PRESENTATION

Box of 1 tube of 10mL Colgate Duraphat. 
For Professional Use Only. Keep out of reach of children.
Store below 25°C
Use within 3 months 

Manufactured in Germany For Colgate Oral Care, 345 George Street Sydney NSW 2000 Australia & 45 Knights Road, Lower Hutt, NZ 
April 2008