Excipient (pharmacologically inactive substance)

What is it?

D&C Red No. 7 Calcium Lake is a drug and cosmetic synthetic dye. The FDA lists it as a safe additive for drugs and cosmetics as per FDA standards. In cosmetics, it can be used externally and in general cosmetics.^[1]

According to the FDA, lakes are formed by reacting straight dyes (such as D&C Red No. 7) with precipitants and salts. Aluminum is often a component, but other precipitants such as calcium or sodium may be used. 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 and lipsticks.^[2]

Its use in coloring pharmaceuticals and cosmetics may only be of quantities allowable by the U.S. FDA. The color additive D&C Red No. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug.^[3]