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Zdrowie i gospodarka · 26/08/2003

FDA Issues Final Rule on Anorectal Drug Products Containing Hydrocortisone and Pramoxine HCl

The FDA has determined that a specific combination of hydrocortisone and pramoxine hydrochloride, used for anorectal purposes, is not considered safe and effective for over-the-counter sale, and is therefore misbranded, despite not being currently marketed as such.

Source: Federal Register — Food and Drug AdministrationOpen original release →