[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1304]

[Page 403-404]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                            Subpart B--Drugs
 
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-
naphthalenesulfonic acid.
    (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

[[Page 404]]

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 
practice:

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 
0.2 percent.
4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 
percent.
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 
practice.
    (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.