Hypochlorous Acid OTC vs. Rx Claims—Understanding the Difference

Effectiveness, cost and convenience are the barometers by which patient satisfaction is measured.  The reality is healthcare costs have risen to a level where patients often have to prioritize pharma treatments.  OCuSOFT® is now offering HypoChlor™ in a 0.02% concentration of Hypochlorous acid.  Avenova™ is marketed as “pure” and proceeds to differentiate its Hypochlorous acid from others (there are many) products—including OCuSOFT®.  The problem is the Food and Drug Administration (FDA) makes no such distinction.   

 

The FDA requires that Hypochlorous acid is registered as a medical device which may be marketed by the filing company as either a prescription (Rx) or over-the-counter (OTC) product.  The basis of Rx vs. OTC relies on the claims that can be made of the product as contrasted with ingredient concentration.  More specific claims can be made if the product is marketed as an Rx (“… for use under the supervision of healthcare professionals…; for moistening absorbent wound dressings and cleaning minor cuts, minor burns…” etc.) however, more general claims are made if the product is OTC (“…immediate care of minor cuts, minor scrapes and minor burns.”)  Generally speaking, the Rx vs. OTC has nothing to do with percentage of principle ingredient.  For example, OCuSOFT® HypoChlorSolution and OCuSOFT® HypoChlor Gel both contain 0.02% Hypochlorous acid and are OTC.  Other company’s brands are available at lower strengths than OCuSOFT® HypoChlor yet one may be Rx and yet another OTC.