FD&C Red No. 3

Excipient (pharmacologically inactive substance)

What is FD&C Red No. 3?

FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Red No. 3, also known as erythrosine, is a synthetic dye with a cherry-pink stain. In foods it is used to dye cake decorating gel, candies and popsicles, among other food items. It is an azo dye, and due to this fact has been replaced with Red #40 (Allura Red), but can still be found in use in the food industry. It is also used as color additive for ingested drugs. It is not listed as approved for use in cosmetics.[1][2]

[1] 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%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.1.31.6

[2] U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and His

Top Medications Containing FD&C Red No. 3

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