---
kind: "section"
citation: "21 C.F.R. § 346.3"
title: "21"
number: "346.3"
heading: "Definitions."
url: "https://uscodex.org/cfr/21/346.3"
---

# §346.3. Definitions.


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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.