FDA Requests Manufacturer to Stop Distribution of Unapproved Dermatologic Products

Crown Laboratories Inc manufactures both prescription and OTC medications, including prescription urea cream and lotion.

Tennessee drug company Crown Laboratories Inc. has agreed to cease the manufacturing and distribution of unapproved and misbranded dermatologic creams and lotions.

The US Department of Justice issued a complaint against the company at the request of the FDA, alleging that the defendants had distributed unapproved and misbranded products, including a series of dermatological products. According to the complaint, the company sold products including creams and lotions intended to treat skin ailments without FDA approval or sufficient evidence demonstrating that the products were safe and effective.

Crown manufactures both prescription and OTC medications including prescription urea cream and lotion. The products specifically referenced in the complaint include Rea Lo Cream, Rea Lo Lotion, Rea Lo 39 Cream, Dermasorb XM Complete Kit, and Sodium Sulfacetamide 10% and Sulfur 5%. The products were marketed as intended treatments for dermatological conditions, such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratosis, and calluses.

The defendants agreed to settle the case and are now bound by a permanent injunction. In addition to halting distribution, officials with Crown must provide a written notice to the FDA stating that they are prepared to destroy all unapproved drugs.


District Court Enters Permanent Injunction Against Tennessee Company and Its CEO to Stop Distribution of Unapproved and Misbranded Drugs [news release]. DOJ’s website. https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-tennessee-company-and-its-ceo-stop. Accessed July 27, 2017.