C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart C—Labeling

21 C.F.R. § 355.55

Principal display panel of all fluoride rinse drug products

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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.”

Notes of Decisions
Cited in 2 cases (2 in the last 5 years), 2026–2026 · leading case: Jason Harden, et al. v. Colgate-Palmolive Co.; Tanisier Clayborne, et al. v. Colgate-Palmolive Co., et al..
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Jason Harden, et al. v. Colgate-Palmolive Co.; Tanisier Clayborne, et al. v. Colgate-Palmolive Co., et al. (N.D. Ill. 2026). “” (Harden ACAC ¶ 183 (quoting 21 C.F.R. § 355.55 ); Cook ACAC ¶ 106.) For mouthrinses containing either 0.”
Jason Harden, et al. v. Colgate-Palmolive Co.; Tanisier Clayborne, et al. v. Colgate-Palmolive Co., et al. (N.D. Ill. 2026). “” (Harden ACAC ¶ 183 (quoting 21 C.F.R. § 355.55 ); Cook ACAC ¶ 106.) For mouthrinses containing either 0.”
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