21 CFR §346.3

1. (a)Analgesic, anesthetic drug. A topically (externally) applied drug that relieves pain by depressing cutaneous sensory receptors.
2. (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.
3. (c)Antipruritic drug. A topically (externally) applied drug that relieves itching by depressing cutaneous sensory receptors.
4. (d)Astringent drug. A drug that is applied topically (externally) to the skin or mucous membranes for a local and limited protein coagulant effect.
5. (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.
6. (f)Intrarectal use. Topical application of an anorectal drug product to the mucous membrane of the rectum.
7. (g)Keratolytic drug. A drug that causes desquamation (loosening) and debridement or sloughing of the surface cells of the epidermis.
8. (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.
9. (i)Protectant drug. A drug that provides a physical barrier, forming a protective coating over skin or mucous membranes.
10. (j)Vasoconstrictor. A drug that causes temporary constriction of blood vessels.