§201.67. Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). — Inbound Citations

A nonprescription drug product approved under section 505(c) or 505(j) of the Federal Food, Drug, and Cosmetic Act with an ACNU as defined in § 201.67(b)(1) is exempt from section 502(f)(1) only if all the following conditions are met:

(2) The statement about the ACNU must be in the form and manner required by § 201.67(c).