4.1 Fluorides

Professionally Applied Fluoride Varnish

Fluoride varnish is gaining acceptance within the oral health and medical communities as a preventive agent, especially for infants and young children. It is easy and quick to apply after removing plaque and oral debris with a toothbrush or gauze. Application is accomplished using a light source such as a flashlight, gloves, something to retract the cheeks (such as a tongue blade or a toothbrush), a 2" x 2" gauze square, an applicator, and the fluoride varnish. The child can eat and drink after application, but the teeth should not be brushed until at least 12 hours later. Fluoride varnish should be applied every 3 to 6 months in children who are at increased risk for dental caries. Fluoride varnish may be the best type of professionally applied fluoride for children with special health care needs.3

Currently, use of fluoride varnish in dental caries prevention is considered “off label” by the Food and Drug Administration (FDA), since FDA has approved fluoride varnish as a “device” (rather than a preventive agent) for use as a cavity liner. Once an agent is approved by the FDA as a device, it can be used off-label. The use of a drug or other agent off-label means that it is being used for a purpose not described in the information provided with the product and for which FDA approval is lacking.4 This does not mean that using fluoride varnish as a preventive agent is illegal or unethical. The Federal Food, Drug and Cosmetic Act does not limit the manner in which physicians or dentists may use approved drugs. Fluoride varnish may be applied at community-based programs such as Head Start or WIC, at university centers of excellence for developmental disabilities, or at other programs.