Active Ingredients: 1.2% (w/w) fluoride ion (F-) from sodium fluoride (NaF) in a 0.1 molar acidulated phosphate foam.

Inactive Ingredients: Purified water, dl-malic acid, sodium phosphate monobasic, sodium methyl cocoyl taurate, flavor, sodium saccharin, sodium benzoate, D&C Yellow #10 (Oranges N Cream and Mint flavors only), FD&C Red #40 (Bubble Gum, Grape, and Oranges N Cream flavors only), FD&C Blue #1 (Mint flavor only), and propellants (inert): isobutane and propane.

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). Ingesting a treatment dose of FluoroFoam APF Foam would result in a fluoride dose at least 250 times lower than the dose consumed daily by the 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 1.2% F- acidulated phosphate fluoride in pediatric patients age 6 to 16 years as a caries preventive is supported by adequate and well-controlled studies.^{2, 3} Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the WARNINGS and CONTRAINDICATIONS 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.

A treatment dose (two trays) of FluoroFoam® APF Topical Foam contains approximately 12 mg fluoride. One 3.4 oz. bottle contains 1,080 mg fluoride.

1. Use after thorough prophylaxis.
2. Shake vigorously 3-4 seconds prior to filling each tray.
3. Break shipping safety tab on first use by pushing forward on the nozzle.
4. Place bottle with nozzle pointed straight downward close to bottom of tray.
5. Slowly press down on the valve trigger. Do not use excessive finger pressure which may result in excess foam dispensed.
6. Move from one end of tray to the other in one motion. Fill tray approximately 1/4 full. Foam will expand to fill tray.
7. Place tray in mouth and have patient bite down lightly for 1 minute or up to 4 minutes.
8. Remove tray and have patient expectorate excess.
9. Inform patient not to eat, drink, or rinse for 30 minutes.