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FD&C Yellow No. 10 Lake

Excipient (pharmacologically inactive substance)

What is FD&C Yellow No. 10 Lake?

FD&C Yellow No. 10 Lake is not approved as a colorant in the US. FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. D&C Yellow No. 10 Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. D&C Yellow No. 10 Lake is approved for use in drugs and cosmetics but it is not approved as a colorant for food. FD&C colors are the colors certified for use by the U.S. FDA in the food, drug, and cosmetic industry. The D&C notation specifies the color is approved only for drugs and cosmetics. The FDA states that D&C Yellow No. 10 Lake may be safely used as a color additive when their specifications are followed. According to the FDA, lakes are formed by reacting straight dyes (such as D&C Yellow No. 10) with precipitants and salts. Aluminum is often a component. Lakes may be used as color additives for tablet coatings due to their stability.[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.;idno=21;cc=ecfr#21:

[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