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D&C Yellow No. 10 Lake

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on Oct 4, 2018.

What is it?

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, as noted by the D&C notation.

FD&C colors are the colors certified for use by the U.S. FDA in the food, drug, and cosmetic industry. D&C Yellow No. 10 Lake may be safely used as a color additive when FDA 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%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.2.31.35

[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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