[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.1991]
 
 [Page 373-374]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                             Subpart B--Drugs
 
 Sec. 73.1991  Zinc oxide.
 
     (a) Identity. (1) The color additive zinc oxide is a white or
 yellow-white amorphous powder manufactured by the French process
 (described as the indirect process whereby zinc metal isolated from the
 zinc-containing ore is vaporized and then oxidized). It is principally
 composed of Zn.
     (2) Color additive mixtures for drug use made with zinc oxide may
 contain only those diluents listed in this subpart as safe and suitable
 in color additive mixtures for coloring externally applied drugs.
     (b) Specifications. Zinc oxide shall conform to the following
 specifications and shall be free from impurities other than those named
 to the extent that such impurities may be avoided by good manufacturing
 practice:
 
 Zinc oxide (as ZnO), not less than 99 percent.
 Loss on ignition at 800 deg.C, not more than 1 percent.
 Cadmium (as Cd), not more than 15 parts per million.
 Mercury (as Hg), not more than 1 part per million.
 Arsenic (as As), not more than 3 parts per million.
 Lead (as Pb), not more than 20 parts per million.
 
     (c) Uses and restrictions. The color additive zinc oxide may be
 safely used for coloring externally applied drugs, including those used
 in the area of the eye, in amounts consistent with good manufacturing
 practice.
     (d) Labeling. The color additive and any mixtues prepared therefrom
 intended solely or in part for coloring purposes shall bear, in addition
 to any information required by law, labeling
 
 [[Page 374]]
 
 in accordance with the provisions of Sec. 70.25 of this chapter.
     (e) Exemption from certification. Certification of this color
 additive is not necessary for the protection of the public health, and
 therefore batches therof are exempt from the certifiation pursuant to
 section 721(c) of the act.
 
 [42 FR 37537, July 22, 1977]