In the early 1970’s, in an attempt to allow faster approval of over-the-counter (OTC) pharmaceutical preparations, the FDA created what is referred to as the “OTC Monograph”. The monograph lists types of products and corresponding ingredients that could be used in them; as long as the monograph was followed, a product could be brought to market without regulatory review. If a product contained a different active ingredient than what was listed on the monograph, pharmaceutical companies were required to go through an expensive and extremely time consuming process of submitting a New Drug Application (NDA). For example, the original OTC Monograph for pain relievers included acetylsalicylic acid (aspirin) and acetaminophen (Tylenol). As long as the new product contained and listed at least one of those active ingredients, those new products could go directly to market without FDA approval. In contrast, when ibuprofen (Motrin) was first introduced, since this ingredient was not included in the OTC Monograph, companies offering ibuprofin-based products were required to submit an NDA. If approved, those products were assigned a prescription only status. Eventually, the FDA added ibuprofen to the OTC Monograph, recategorizing Motrin and other ibuprofin-based products to OTC status.
The same principles apply to cerumen removal drops. The current OTC Monograph related to ear wax removal drops lists a 6.5% solution of carbamide peroxide in an anhydrous glycerine base as the only approved active ingredient. Why am I telling you this? All OTC ear wax removal systems will contain the same active ingredient. In other words, brand name products such as Debrox, Murine, and Audiologist’s Choice are all the same product. The difference between these brands is packaging and price. Audiologist’s Choice tends to be significantly less expensive than most available brands. Knowing this information, it is clear that the choice of audiologists is to use and recommend the Audiologist’s Choice brand.
This blog post was contributed by Bob Kemp, Founder and CEO of Oaktree Products, Inc., a multi-line distributor of hearing health care products based in the St. Louis, MO. As a microbiologist, Bob has been educating audiologists and other hearing health care providers in the areas of infection control and cerumen management. Oaktree Products serves as a product and information resource to the hearing industry. For more information, visit http://www.oaktreeproducts.com/.
