[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1991]
[Page 370]
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
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 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]
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