Synthetic Ferric Oxide Black
Excipient (pharmacologically inactive substance)
What is Synthetic Ferric Oxide Black?
FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. Ferric oxide black (Fe3O4), also known as iron (III) oxide, is a coloring agent for tablets and capsules and is used in the pharmaceutical industry. Iron oxides are also commonly used in the cosmetics industry. Iron oxides for use in pharmaceutical manufacturing may also be synthetic.
 Dave RH. Overview of pharmaceutical excipients used in tablets and capsules. Drug Topics (online). Advanstar. 10/24/2008 http://drugtopics.modernmedicine.com/drugtopics/Top+News/Overview-of-pharmaceutical-excipients-used-in-tabl/ArticleStandard/Article/detail/561047. Accessed 08/19/2011
 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
Top Medications Containing Synthetic Ferric Oxide Black
- Acyclovir 200 mg (Actavis)
- Naproxen 375 mg (Watson Pharmaceuticals)
- Palladone 32 mg (Purdue Pharma LP)
- Palladone 24 mg (Purdue Pharma LP)
- Palladone 12 mg (Purdue Pharma LP)
- Palladone 16 mg (Purdue Pharma LP)
- Phrenilin with Caffeine and Codeine acetaminophen 325 mg / butalbital 50 mg / caffeine 40 mg / codeine phosphate 30 mg (Valeant Pharmaceuticals North America)
- SANSERT 2 MG (Novartis Pharmaceuticals)