Acclean 60 Second Fluoride Treatment

A topical anticaries preparation for professional use only.

1.23% fluoride ion from sodium fluoride. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavored.

Apply a small amount of fluoride toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute.

After use, expectorate.

For best results, do not eat, drink, or rinse for 30 minutes.

Use twice daily as your normal dentifrice or as directed by your dental professional.

Data not available

Data not available

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. Adverse effects on reproduction have been reported in animals exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other animal studies reported that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Animal studies have reported that fluoride crosses the placenta, but only 0.01% of the amount administered is incorporated in fetal issues. Maternal animal exposure to 12.2 mg fluoride/kg of body weight or 13.1 mg/kg of body weight did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations.

Fluoride topical has been assigned to pregnancy category B by the FDA. Animal studies have shown that fluoride is not a teratogen. There are no controlled data in human pregnancy. Fluoride topical should be given during pregnancy when need has been clearly established.