(a) An over-the-counter external analgesic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

As used in this part:

(a) Male genital desensitizing drug product. A drug product applied to the penis to help in temporarily slowing the onset of ejaculation.

(b) [Reserved]