Phos-Flur Gel contains 0.5% fluoride ion (F-) from 1.1% sodium fluoride in an aqueous gel containing 0.1 molar phosphate, pH 5.1. For daily self-topical use as a dental caries preventive in adults and pediatric patients age 6 years and over. This prescription product is not a dentifrice.
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Ingredients:

Active Ingredients: Sodium fluoride (NaF) 1.1% (w/v).

Inactive Ingredients:Purified water, glycerin, PEG-12, xanthan gum, propylene glycol, sodium phosphate monobasic, flavor, poloxamer 407, nipastat, sodium saccharin, polysorbate 20, sodium benzoate, disodium EDTA dihydrate, phosphoric acid, and certified dyes {FD&C Red #40 (Cherry flavor only); FD&C Blue #1 and D&C Yellow #10 (Mint flavor only)}.
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Clinical Pharmacology:

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
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Indications and Usages:

A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride in an acidulated gel is safe and extraordinarily effective as a caries preventive in orthodontic patients when applied frequently with mouthpiece applicators.^1-5 Phos-Flur Gel in a squeeze tube is a particularly convenient dosage form which permits the application of a thin ribbon of gel onto a toothbrush as well as a mouthpiece tray.
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Contraindications:

Do not use in pediatric patients under 6 years of age unless recommended by a dentist or physician.
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Warnings:

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. 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 topical gel 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 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 Phos-Flur Gel is at least 2,400 times lower than the concentration 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: : The use of Phos-FlurÒ Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander et al.³,⁴ Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the WARNINGS and CONTRAINDICATIONS sections.
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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: