Hi Winston.
I strongly recommend being very careful about changing the wording in the monograph. It the statement is in quotation marks and it can apply to your product, you have the responsibility to use the statement as it is written. If the statement does not apply to your product, you have the responsibility to omit the statement. Changing things in the drug facts box is not something that I advise in general. Stick to the script. Think of it as a way to ensure you have complete regulatory (and in some cases legal) cover if anything were to be questioned. Remember - OTC have the benefit of an "express" preemption rule in the law provided that you follow the drug facts labeling as it is written. Additionally, if you are ever questioned about a particular product, it is far more relaxing to be in the midst of an inspection with questions being asked when the drug facts panel is only using the verbiage of the FDA itself in the monograph.
Now, can you change the wording? Yes, you can. There is a provision in almost every monograph I can think of that says something like "Other truthful and non-misleading statements" can be used. However, you want to carefully document exactly how you arrive at your conclusion that this statement is truthful and non-misleading. So in this situation, it is reasonable to assume that if your product is meant to be left on (I am imagining a salicylic acid cream spot treatment type product since you did not specify the type of product but I am inferring from your suggested change that this is the sort of product involved) you would not want to instruct the consumer to wash or rinse off after use. In that case, I would generally put a memo to file that explains specifically what the situation is, specifies the product as a leave-on product, note that use of the rinse off provision would actually hurt the efficacy of the product, provide whatever summary of safety data you might have on the product (safety-in-use, HRIPT, dermatologist testing, etc.) and then note that your conclusion is that the more appropriate direction is "wash area before using the product" as opposed to the monograph statement of "rinse off after use." This provides you with the information you will need to be able to show the inspection team should a question ever arise and it shows that you considered the issue before shipping product to the market.
------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
------------------------------
Original Message:
Sent: 18-Aug-2023 10:21
From: Winston Costa Pereira
Subject: Regarding the OTC drug Facts label.
Hi all,
This is in regards to an OTC label that is part of the FDA monograph. I have a question about an anti acne label. There are 2 types of products namely rinse off and leave on. If the monograph label is geared to rinse off can the statement "rinse off after use" be replaced by "wash area before using the product".
The monograph only states that active ingredients like Salicylic acid 3% must use the monograph for anti acne products but has no difference in leave on and rinse off products. Are the directions a guidance and some can be omitted? What if you wish to add a direction like Wash area before use (that is not what is in the monograph)?
Kind regards,
Winston Costa Pereira
Sent from my iPhone