D&C Red No. 28
Excipient (pharmacologically inactive substance)
Medically reviewed by Drugs.com. Last updated on Feb 15, 2019.
What is it?
D&C Red No. 28, also known as Disodium 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (C20H2O5Br4Cl4Na2) is a dye approved by the FDA for use in drugs and cosmetics according to the specifications set forth by the FDA. FD&C Red No. 28 is not approved for use in foods.
FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. These colors are then certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics.
 U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm
 Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A18.104.22.168.27;idno=21;cc=ecfr#21:22.214.171.124.126.96.36.199
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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