21 CFR 355.55 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 370-499) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 370-499) — Drugs For Human Use (Subpart A To Parts 370-499) — Anticaries Drug Products For Over-The-Counter Human Use (§ 355.1 To § 355.70) — Labeling (§ 355.50 To § 355.60) — Principal display panel of all fluoride rinse drug products.
4 Aug 2016
In addition to the statement of identity required in § 355.50, the following statement shall be prominently placed on the principal display panel: “IMPORTANT: Read directions for proper use.”