Next Generation Means There’s an “OLD” Generation
In 1972, the FDA created a set of standards and criteria (called “monographs”) for all existing over-the-counter (OTC) medications sold at retail up to the early 1970’s. The monographs provide a list of the approved “active ingredients” for each category along with allowable dosages of the active ingredient(s) for any given product. There are 80 categories of monographs listed in the Federal Code that includes every type of OTC product you can find on the retail shelf.
Some products, like BenGay and IcyHot, met the criteria of the monograph although the formulations were developed as long ago as 1898 (see figure below). IcyHot was developed in 1934 and for the most part, is pretty much the same formulation.
New Developments Provide Better Overall Relief
Surprisingly, the monograph for topical pain relievers has not been updated since 1972. In fact, medical research since the mid-1980’s has taken a NEW approach to treating musculoskeletal pain by focusing on the real cause of chronic pain – inflammation!
The destruction force of inflammation is that it resides in the affected area attacking and destroying connective tissue. Pain, on the other hand, does NOT reside in the affected area but is a signal sent from the brain warning you that there is a problem in the affected area.The typical topical analgesic you find on the shelf today, compliant with1972 standards, simply masks the pain and provides little to reduce the destructive toll on your connective tissue caused by inflammation.
MiraFlex, Inflammation and Faster, More Complete Relief
Armed with current medical findings with regard to the collateral damage wrought by inflammation, MiraFlex-R3 was developed to calm inflammation with two powerful, all natural anti-inflammatories. MiraFlex also employs the strongest two pain relievers approved for topical applications to provide quick relief from pain caused by arthritis and trauma to the joints, muscles and connective tissue. This potent combination of anti-inflammatories and analgesics tis wrapped in a proprietary delivery system to ensure that the therapeutic value of MiraFlex effectively and efficiently reaches the affected area. By providing the body relief from pain and the destructive force of inflammation, you not only get better mobility and range of motion but you have a chance to improve the condition. The result is faster, more complete relief.
A Side Note:
The result of creating the monographs is that all products in any given category must conform to the criteria provided by the monograph. That means that all manufacturers producing a product in a category are required to select only the active ingredients listed in the monograph for that category. That’s why most brands look, feel, smell and work pretty much the same.
In order for a manufacturer to use a “new” active ingredient in their product, they are required to file a “new drug application” (NDA). NDA’s are expensive and can take a decade or more for approval and addition to the monograph. But the real issue is that after all the time and expense incurred in research and development, the new ingredient is immediately available to other manufacture by virtue of inclusion to the monograph.
Today 97% of new OTC introductions are medications that were prescription medicines where patents have expired or the prescription has been diluted to some extent. The monograph for topical analgesics, the category for MiraFlex, has not been updated since 1972, long before inflammation was considered a threat to improving your condition.