§ 346.3. Definitions.
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/us/cfr/t21/s§ 346.3·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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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§ 346.3
Definitions.
Fed. Reg.×2
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