Regulatory Open Forum

Looking for resource links for OTC drug monographs. Specifically for Menthol and Camphor. 

I am having trouble locating what I need for labeling and claims for the FDA OTC portal.

Any guidance appreciated!

Hi,

It depends on what type of OTC drug you are looking at.  Camphor and menthol can be found in cough colds etc. and anorectals.  21 CFR 341 and 21 CFR 346. 

Looking for resource links for OTC drug monographs. Specifically for Menthol and Camphor. 

I am having trouble locating what I need for labeling and claims for the FDA OTC portal.

Any guidance appreciated!

Hi Anon.

Let me expand on Rhonda's response here: the labeling for an OTC if a monograph is used is actually pretty simple and straightforward.  So as Rhonda noted the first step is to decide which monograph(s) might apply.  Once that information is known, then the required labeling almost entirely comes from the monograph (the limitation here being the net contents and domicile information will be product SKU and company specific).  If you look at the monographs, the FDA literally outlines exactly what information needs to be placed within the drug facts box (yes, a drug facts box is required for all OTC products unless the packaging is qualified to be too smalll to contain the information and even then a modified drug facts declaration is still required), how it is organized, and what needs to be separated by what type of separation.  In addition, FDA has also published previously examples of what a compliant drug facts box might look like on different sizes, shapes, and types of product packaging.  Simply follow the requirements as they are listed.

Example - Once you determine you product monograph, you can determine first what your statement of identity needs to be.  That is fairly straightforward since the product will determine that many times for you.  Now, determine if your product meets the monograph requirements for active ingredient(s) and level(s) in the formulation.  Assuming it does, you have now started both to complete you PDP (active and percentage needs to be listed on PDP) as well as your drug facts box since you have now determined your active ingredient and percentage which are two key requirements for the first segment of the drug facts box (DFB).  The third required piece of information in the first segment of the DFB (Active ingredient) is the "Purpose" and again this is spelled out within the monograph.  The next segment is for Uses and FDA has published the allowable usage terminology in the monograph as well.  Yes, there will be options in some cases that are typically noted in parentheses with the work "optional" or "choose" or something like that to note that you have the option to include or not ("optional") or that you have a choice of the wording that is allowed ("choose").

If you follow the monograph in this manner (and you look into the actual monograph regulation to determine what thickness of separating lines and type format (bold, italics, etc.) is required then you will have no issue completing the DFB.  And honestly, once the DFB is completed you are pretty well set.  Just remember that there are rules about what information is allowed and only that information should appear in your DFB.  Also important to note is that the regulations also specify that no extraneous information can be placed around the DFB if it potentially could cause a person to be unable or less likely to look at, read and follow the information in the DFB so watch out for that!

Hi,

It depends on what type of OTC drug you are looking at.  Camphor and menthol can be found in cough colds etc. and anorectals.  21 CFR 341 and 21 CFR 346. 

Looking for resource links for OTC drug monographs. Specifically for Menthol and Camphor. 

I am having trouble locating what I need for labeling and claims for the FDA OTC portal.

Any guidance appreciated!