Excipient (pharmacologically inactive substance)

What is it?

FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. The color additive D&C Red No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.

Lakes are formed by reacting straight dyes (such as D&C Red No. 6) with precipitants and salts, according to the FDA. 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.

Additives used in coloring pharmaceuticals and cosmetics may only be of quantities allowable by the U.S. FDA. The color additive D&C Red No. 6 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.^[1][2][3]