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.
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. 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.
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