D&C Red No. 33

Excipient (pharmacologically inactive substance)

What is D&C Red No. 33?

D&C Red No. 33 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, including lipsticks, but is not to be used in cosmetics close to the eye.[1]

The color additive D&C Red. No 33 may be safely used for coloring ingested drugs in amounts not to exceed 0.75 milligram per daily dose of the drug. D&C Red No. 33 may be safely used for coloring externally applied drugs, mouthwashes, and dentifrices in amounts consistent with current good manufacturing practice. D&C Red No. 33 may also be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 33 may be safely used for coloring mouthwashes (including breath fresheners), dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice.[2]

[1] U.S. Food and Drug Administration (FDA). Cosmetics. Color Additives Permitted for Use. Accessed 8/20/2012. http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/ucm109084.htm

[2] Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Accessed online 8/20/2012. 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#21:1.0.1.1.27.2.31.24

Top Medications Containing D&C Red No. 33

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