21 C.F.R. § 346.3 Definitions.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A—General Provisions
§ 346.3 Definitions.