21 C.F.R. § 346.3
Definitions.
Cite as 21 C.F.R. § 346.3 (2026)
As used in this part:
(a)
Analgesic, anesthetic drug.
A topically (externally) applied drug that relieves pain by depressing cutaneous sensory receptors.
(b)
Anorectal drug.
A drug that is used to relieve symptoms caused by anorectal disorders in the anal canal, perianal area, and/or the lower rectal areas.
(c)
Antipruritic drug.
A topically (externally) applied drug that relieves itching by depressing cutaneous sensory receptors.
(d)
Astringent drug.
A drug that is applied topically (externally) to the skin or mucous membranes for a local and limited protein coagulant effect.
(e)
External use.
Topical application of an anorectal drug product to the skin of the perianal area and/or the skin of the anal canal.
(f)
Intrarectal use.
Topical application of an anorectal drug product to the mucous membrane of the rectum.
(g)
Keratolytic drug.
A drug that causes desquamation (loosening) and debridement or sloughing of the surface cells of the epidermis.
(h)
Local anesthetic drug.
A drug that produces local disappearance of pain, burning, itching, irritation, and/or discomfort by reversibly blocking nerve conduction when applied to nerve tissue in appropriate concentrations.
(i)
Protectant drug.
A drug that provides a physical barrier, forming a protective coating over skin or mucous membranes.
(j)
Vasoconstrictor.
A drug that causes temporary constriction of blood vessels.