D&C Red No. 28 Aluminum Lake
Excipient (pharmacologically inactive substance)
What is it?
D&C Red No. 28 Aluminum Lake is a dye approved by the FDA for use in drugs and cosmetics according to the specifications set forth by the FDA. D&C Red No. 28 Aluminum Lake is not approved for use in foods. According to the FDA, lakes are formed by reacting straight dyes (such as D&C Red No. 28) with precipitants and salts. Aluminum is often a component. Lakes may be used as color additives for tablet coatings due to their stability, and may also be used for cosmetics such as eye shadows or lipsticks. Its use in coloring pharmaceuticals and cosmetics may only be of quantities allowable by the FDA.
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%3A220.127.116.11.27;idno=21;cc=ecfr#21:18.104.22.168.22.214.171.124