54 American Dental Association Dietary fluoride supplements can be considered for infants and children aged 6 months to 16 years. Compliance with the daily administration of the supplement will enhance the cavity prevention benefits. Providers should consider and monitor the ability of the caregiver and child to adhere to the schedule. If compliance is an issue, another mode of fluoride delivery should be considered.41 Use of Over the Counter Fluoride-Containing Dental Products in the Home Parents, caretakers and health care professionals should judiciously monitor use of all fluoride- containing dental products by children under age six. As is the case with any therapeutic product, more is not always better. The same is true for most products found in the medicine cabinet care should be taken to adhere to label directions on fluoride prescriptions and over-the-counter products (e.g., fluoride toothpastes and rinses). The ADA recommends the use of fluoride mouthrinses, but not for children less than six years of age because they may swallow the rinse.93 These products should be stored out of the reach of children. Additional information regarding the use of mouthrinses can be found on the ADA website.93 Drinking Water That Has Been Fluoridated at the Recommended Levels In 2015, the U.S. Public Health Service made a recommendation on the level of fluoride to be used in water fluoridation (0.7mg/L) to provide the best balance of protection from tooth decay while limiting the risk of dental fluorosis.16 Additional information on this topic can be found in this Section, Question 19. Drinking Water With High Levels of Naturally Occurring Fluoride In areas where naturally occurring fluoride levels in ground water are higher than 2 mg/L, the U.S. EPA has recommended that consumers should consider action to lower the risk of dental fluorosis for young children such as providing drinking water from an alternative source.32 Families with young children on community water systems should contact their water suppliers to ask about the fluoride level in their drinking water. Consumers with private wells should have the water tested yearly to accurately determine the fluoride content. Consumers should consult with their dentist regarding water-testing results and discuss appropriate dental health care measures. In homes where young children (with developing permanent teeth) are faced with consuming water with a fluoride level greater than 2 mg/L, families should use an alternative primary water source that contains the recommended level of fluoride for drinking and cooking.32 Additional information on this topic can be found in this Section, Question 21. 30. Why is there a warning label on a tube of fluoride toothpaste? Answer. The U.S. Food and Drug Administration (FDA) has established regulations for warning labels for a number of over-the-counter items it considers safe and effective including fluoride toothpaste. Fact. The FDA has published regulations regarding warning labels for over-the-counter (OTC) drugs in the Code of Federal Regulations (CFR).94 All the non-prescription drugs covered by these regulations must display the general warning “Keep out of the reach of children” in bold type. The regulations outline three additional warning statements (based on the most likely route of exposure) to be listed on the label in the event the drug is misused. While they vary slightly, they all include the following language: “…get medical help or contact a Poison Control Center right away.”94 In the CFR, the FDA has outlined the drug categories to be covered by these warning labels.95 Some of the 26 categories include antacids, allergy treatment products, antiperspirants, cold remedies, ophthalmic products and dentifrices and dental products such as analgesics, antiseptics, etc.95