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FD&C Red No. 3

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on Apr 7, 2019.

What is it?

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. Red #40 (Allura Red), is an azo dye, but it is often used in place of Red Dye #3 and can still be found in use in the food industry. Red Dye #3 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 Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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