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74.1304 FD&C Red No. 4.

Home > Regulations > Listing of color additives subject to certification > 74.1304 FD&C Red No. 4.






[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: 21CFR74.1304]



[Page 399]

 

                        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 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.










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 1304


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