{"data":{"id":"us/21-cfr-346.3","jurisdiction":"us","citation":"21 CFR 346.3","heading":"Definitions.","body":"As used in this part:\n(a) Analgesic, anesthetic drug. A topically (externally) applied drug that relieves pain by depressing cutaneous sensory receptors.\n(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.\n(c) Antipruritic drug. A topically (externally) applied drug that relieves itching by depressing cutaneous sensory receptors.\n(d) Astringent drug. A drug that is applied topically (externally) to the skin or mucous membranes for a local and limited protein coagulant effect.\n(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.\n(f) Intrarectal use. Topical application of an anorectal drug product to the mucous membrane of the rectum.\n(g) Keratolytic drug. A drug that causes desquamation (loosening) and debridement or sloughing of the surface cells of the epidermis.\n(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.\n(i) Protectant drug. A drug that provides a physical barrier, forming a protective coating over skin or mucous membranes.\n(j) Vasoconstrictor. A drug that causes temporary constriction of blood vessels.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE","Subpart A—General Provisions"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"0ba56db3c9a21538986c852aa350eaee987b9b6c67f14652a5d29939267ed301","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-346.1","next":"us/21-cfr-346.10"},"notice":"GroundRules: Original legal text. Not legal advice."}