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73.1991 Zinc oxide.

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[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR73.1991]



[Page 368]

 

                        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 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]



[[Page 369]]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1991


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