[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of
Sec. 74.1304 FD&C Red No. 4.
(a) Identity. (1) The color additive FD&C Red No. 4 is principally
the disodium salt of 3-[(2,4-dimethyl-5-sulfophenyl)azo] -4-hydroxy-1-
(2) Color additive mixtures for use in externally applied drugs made
with FD&C Red No. 4 may contain only those diluents that are suitable
and that are listed in part 73 of this chapter for use in color additive
mixtures for coloring externally applied drugs.
(b) Specifications. FD&C Red No. 4 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
Sum of volatile matter (at 135 [deg]C.) and chlorides and sulfates
(calculated as sodium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than
4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2
Subsidiary colors, not more than 2 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 87 percent.
(c) Uses and restrictions. FD&C Red No. 4 may be safely used in
externally applied drugs in amounts consistent with good manufacturing
(d) Labeling. The label of the color additive and any mixtures
prepared therefrom intended solely or in part for coloring purposes
shall conform to the requirements of Sec. 70.25 of this chapter.
(e) Certification. All batches of FD&C Red No. 4 shall be certified
in accordance with regulations in part 80 of this chapter.
Additives that reference this regulation: