Simplest answer is:
If the statement is in quotes, then the wording is expected to be exactly as written in the monograph.
If the statement is not in quotes, then you have some latitude to get the overall message across. I have not seen many if any monographs with statements not in quotation marks so generally I interpret that to mean that the statement as noted is required exactly as written in the Federal Register notice.
If the product requires a drug facts box, the statement is required as written. If it does not require a drug facts box then you have no issue with the statement since the monograph speaks generally (with limited exceptions!) to what is found by the consumer in the drug facts box.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 22-Oct-2019 10:21
From: Anonymous Member
Subject: OTC Monograph
This message was posted by a user wishing to remain anonymous
I am curious to know when getting ready to market a OTC acne product. Does the labeling of the product have to word for word what is written in the monograph or is it to be used as a guideline to construct the label copy? For example: Warnings The labeling states "Do not use on [bullet] broken skin [bullet] large areas of the skin."
Just want to get an idea if it has to be written verbatim.
And if so does this apply to products not for sale and for sampling purposes?