An aqueous solution of 1.09% sodium fluoride, 0.4% stannous fluoride and 0.14% hydrogen fluoride (equivalent to 0.717% fluoride and 0.303% tin).
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Ingredients:

Active ingredients: 1.09% sodium fluoride, 0.4% stannous fluoride and 0.14% hydrogen fluoride (equivalent to 0.717% fluoride and 0.303% tin) (%w/v).

Inactive ingredients: Purified water, phosphoric acid.
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Clinical Pharmacology:

Scanning confocal microscopy (SCM) of DentinBloc-treated dentin in vitro shows particulate obturation in a majority of the dentin tubule orifices.¹ This observation may explain the prompt relief of hypersensitivity following application of this solution,^2-4consistent with the hydrodynamic theory.⁵ The particulate matter might contain tin and fluoride, observed in a related formulation.⁶
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Indications and Usages:

For prompt temporary relief of exposed dentin hypersensitivity.
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Contraindications:

Not for use in pediatric patients.
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Warnings:

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Use cautiously in patients with porcelain or ceramic restorations as per PRECAUTIONS below. Read directions carefully before using. Keep out of reach of infants and children.
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Precautions:

General: Laboratory tests indicate that repeated use of acidulated phosphate fluoride may cause dulling of porcelain and ceramic restorations unless protected from contact. Do not place in porcelain or glass containers. Not for systemic treatment. DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies that have been conducted in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). The ingestion of a treatment dose of DentinBloc is at least 1000 times lower than the high concentrations tested in farm-raised fox. No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/w) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
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Adverse Reactions:

Contact with abraded or sensitive gingival tissue may produce discomfort. Allergic reactions and other idiosyncrasies are rarely reported.
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Overdosage:

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution), and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (unit dose) of DentinBloc® Dentin Desensitizer contains 5.4 mg fluoride.
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Dosage and Administration:

Each unit dose contains 0.75 grams of solution. Saturated foam applicator should be applied to the tooth surface for one minute. Use constant light pressure. Expectorate after application. Sequential one minute treatments may be necessary.
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How Supplied:

Box of 50 Unit Dose Treatments NDC#0126-2381-50 (professional use only)
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Storage:

Store at controlled room temperature, 20-25°C (68-77°F).
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References:

1. E.S. Duke and L. Conn, Morphological evaluation of dentin treated with desensitizing agents, On file at Colgate-Palmolive Technology Center.
2. W. J. Thrash, D. L. Jones and W. J. M. Dodds, Effect of a Fluoride Solution on Dentinal Hypersensitivity, Am. J. Dent., 5, 299-302 (1992).
3. W.J. Thrash, H.L. Dorman and F.D. Smith, A Method to Measure Pain Associated with Hypersensitive Dentin, J. Periodontology, 54, 160-162 (1983).
4. W.J. Thrash, M.W.J. Dodds and D.L. Jones, The Effect of Stannous Fluoride on Dentinal Hypersensitivity, Int. Dent. J., 44, 107-118 (1994).
5. M. Brannstrom, G. Johnson and L. Lindel, Fluid Flow and Pain Response in the Dentin Produced by Hydrostatic Pressure, Odontol. Revy, 20, 15-16 (1969).
6. J.E. Ellingsen and G. Rolla, Treatment of Dentin with Stannous Fluoride- SEM and Electron Microprobe Study, Scand. J. Dent. Res., 95, 281-6 (1987).
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