Excipient (pharmacologically inactive substance)

What is it?

D&C Red No. 28, also known as Disodium 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (C20H2O5Br4Cl4Na2) is a dye approved by the FDA for use in drugs and cosmetics according to the specifications set forth by the FDA.^[1] FD&C Red No. 28 is not approved for use in foods.

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.^[1][2]