The last half-century in the US has demonstrated dramatic reductions in decay rates. While the causes of this reduction are multifactorial, it is clear that enormous benefits in caries reductions must be attributed to both systemic and topical mechanisms of the fluoride ion. The efficacy of topical fluoride, both home and professional applications, are well established.

Fluoride varnishes are a type of topical fluoride and appear to be comparable in efficacy to traditional fluoride gels which currently are being used in dental practice. Use of approved fluoride varnishes for caries prevention, however, is considered to be an "off-label" use of an approved drug.The "off-label" use of drugs is a practice that is common in medicine with a number of drugs that have multiple efficacious therapeutic uses. If one considers that the application of topical fluoride for a patient who is at risk for caries is the standard of practice for his/her community then the selection of an approved fluoride varnish is a reasonable choice.