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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 21Chapter ISubchapter DPart 346Subpart A → §346.3


Title 21: Food and Drugs
PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A—General Provisions


§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.

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