Products:

Colgate® Duraphat® Varnish

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FLAVORS AND SIZES:
Product #Description
733033Colgate® Duraphat®: 10 mL tube
COMPOSITION:

1 ml of this suspension contains 50 mg sodium fluoride, equivalent to 22.6 mg fluoride, in an alcoholic solution of natural resins.

PROPERTIES:

DURAPHAT® displays a strong desensitizing effect when applied to affected dentinal surfaces. It is remarkably water tolerant and covers even moist surfaces with a well-adhering film of varnish, setting in saliva and obturating orifices of the dentinal tubules, providing desired reduction of patency to the tooth pulp.

INDICATIONS:

Treatment of dentinal hypersensitivity.

APPLICATION:

Depending on the access, Duraphat® fluoride varnish can be applied by use of cotton swabs, a brush or with a probe. The natural color provides visual control. Duraphat® covers even moist teeth with a film of varnish for several hours with obturation of openings of dentinal tubules. Application of the varnish is extremely rapid. Since no drying is required, the patient can leave immediately after the application. It is recommended that the patient does not eat hard foods or brush for at least two hours after the application.

CONTRAINDICATIONS:

Duraphat® is contraindicated in patients with ulcerative gingivitis or stomatitis or known sensitivity to colophony (kolophonium) or other ingredients. Not for ingestion during application (not for systemic treatment).

INTERACTIONS WITH OTHER SUBSTANCES:

On the day of Duraphat® application, other fluoride preparations, such as fluoride gels, should not be administered. Routine regimens of fluoride tablets should be suspended for several days after treatment.

ADVERSE REACTIONS:

In case of disposition to allergic reactions, edematous swellings have been reported only in rare instances, especially after application to extensive surfaces. In extremely rare instances, attacks of dyspnea have occurred in asthmatic children. Patients known for sensitive stomach may occasionally experience nausea with extensive applications. In any case of intolerance, the varnish layer can easily be removed by brushing and rinsing.

HOW SUPPLIED:
0.34 fl. oz (10 mL) net wt. tubes

STORAGE:

Store at controlled room temperature 20-25C (68-77F)

CAUTION:

Federal (USA) law restricts this device to sale by or on the order of a dentist or physician.

MANUFACTURE/DISTRIBUTION:

Colgate Oral Pharmaceuticals
Subsidiary of Colgate-Palmolive Company
300 Park Avenue
New York, NY 10022

  1. Clark DC, Hanley JA, Geoghegan S, Vinet D. The effectiveness of a fluoride varnish and a desensitizing toothpaste in treating dentinal hypersensitivity. J Periodontol Res. 1985;20:212-219.
  2. Clark RE, Papas AS. Duraphat vs extra-strength Aim in treating dentinal hypersensitivity. J Dent Res. 1992;71 (special issue):628.
  3. Ekstrand J, Koch G, Lindgren LE, Petersen LG. Pharmacokinetics of fluoride gels in children and adults. Caries Res. 1981;15:213-220.
  4. Ekstrand, J, Koch G, Petersson LG. Plasma fluoride concentration and urinary fluoride excretion in children following application of the fluoride-containing varnish Duraphat. Caries Res. 1980;14:185-189.
  5. Data on file. Colgate Oral Pharmaceuticals.
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