[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: 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.