[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR347.3]

[Page 275]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 347_SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table 
 
                      Subpart A_General Provisions
 
Sec.  347.3  Definitions.

    As used in this part:
    Astringent drug product. A drug product applied to the skin or 
mucous membranes for a local and limited protein coagulant effect.
    Lip protectant drug product. A drug product that temporarily 
prevents dryness and helps relieve chapping of the exposed surfaces of 
the lips; traditionally called ``lip balm.''
    Poison ivy, oak, sumac dermatitis. An allergic contact dermatitis 
due to exposure to plants of the genus Rhus (poison ivy, poison oak, 
poison sumac), which contain urushiol, a potent skin-sensitizer.
    Skin protectant drug product. A drug product that temporarily 
protects injured or exposed skin or mucous membrane surfaces from 
harmful or annoying stimuli, and may help provide relief to such 
surfaces.

[68 FR 33376, June 4, 2003]