21 CFR 74.1254 - D&C Orange No. 4.

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§ 74.1254 D&C Orange No. 4.

(a)Identity.

(1) the color additive D&C Orange No. 4 is principally the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid.

(2) Color additive mixtures for use in externally applied drugs made with D&C Orange 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. D&C Orange 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 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
2-Naphthol, not more than 0.4 percent.
Sulfanilic acid, sodium salt, not more than 0.2 percent.
Subsidiary colors, not more than 3 percent.
4,4′-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent.
Lead (as Pb), not more than 20 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. D&C Orange No. 4 may be safely used for coloring 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 § 70.25 of this chapter.

(e)Certification. All batches of D&C Orange No. 4 shall be certified in accordance with regulations in part 80 of this chapter.

[ 42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, 1981]

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 74 after this date.

  • 2017-01-23; vol. 82 # 13 - Monday, January 23, 2017
    1. 82 FR 7648 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016.
      21 CFR Parts 73 and 74
The section you are viewing is cited by the following CFR sections.

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2017-01-23; vol. 82 # 13 - Monday, January 23, 2017
    1. 82 FR 7648 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016.
      21 CFR Parts 73 and 74