[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR346.3]

[Page 261]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 346--ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 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.