Anticaries Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment; Partial Delay of Effective Date

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) anticaries drug products (products that aid in the prevention of dental cavities) are generally recognized as safe and effective and not misbranded (60 FR 52478, October 6, 1995). This final rule makes a nonsubstantive change in the definition of a dentifrice, clarifies how OTC dentifrice gels are included in certain labeling aspects of the final monograph, and clarifies that the second general warning regarding ``accidental ingestion'' is the statement to be used for OTC fluoride-containing dentifrice, treatment rinse, and preventive treatment gel drug products. This amendment also revises the second general warning statement to indicate to consumers that ``accidental ingestion'' of these products means swallowing more than is used during normal brushing or rinsing. Because of the need to revise labeling for this minor revision, the agency is delaying the effective date of the regulation to provide manufacturers with an additional 6 months to comply with the labeling requirements of the monograph. This final rule is part of the ongoing review of OTC drug products conducted by FDA.