§346.3. Definitions.

Analgesic, anesthetic drug. A topically (externally) applied drug that relieves pain by depressing cutaneous sensory receptors.

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.

Antipruritic drug. A topically (externally) applied drug that relieves itching by depressing cutaneous sensory receptors.

Astringent drug. A drug that is applied topically (externally) to the skin or mucous membranes for a local and limited protein coagulant effect.

External use. Topical application of an anorectal drug product to the skin of the perianal area and/or the skin of the anal canal.

Intrarectal use. Topical application of an anorectal drug product to the mucous membrane of the rectum.

Keratolytic drug. A drug that causes desquamation (loosening) and debridement or sloughing of the surface cells of the epidermis.

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.

Protectant drug. A drug that provides a physical barrier, forming a protective coating over skin or mucous membranes.

Vasoconstrictor. A drug that causes temporary constriction of blood vessels.