The FDA (Federal Drug Administration) of the United States allows manufacturers to use OTC ingredients in certain concentrations and combinations without having to go through the many years of testing that new prescription drugs must go through to be proven safe and effective. The FDA has developed what they call “monographs” which are approved “recipes and active ingredients” for different types of afflictions. (Pranicure falls within the monograph for anal ointments.) As long as a manufacturer stays within the monograph guidelines, the final product is approved and can be sold to the public. Basically, once an ingredient (for example zinc oxide or menthol) has been proven safe, then future manufacturers can use these ingredients without “re-proving” safety or effectiveness. Only NEW drugs must be individually inspected and approved by the FDA. Click here to see the FDA website which explains the “OTC drug approval” through their monograph system.
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