Hi Anon.
I have not seen a specific expectation from the FDA or even an industry standard in terms of how strong the binding/adherence needs to be. However, the FDA does require that the product be labeled in such a way as to comply with all of the labeling requirements of the Act as well as the implementing regulations so you need to ensure that the label will make it safely to the end consumer and that the consumer will be able to have the reference of the labeling for as long as the product remains within expiration. This is a long way to say that "it depends" on many factors including length of expiration, where it is likely to be used/stored, how many applications/uses, standard use instructions (can it be used 4 times daily for 7 days or is it a sunscreen that can be used as often as desired/needed for as long as the product remains within expiration before needing to consult with a physician?) and how the information is presented (standard side or back panel, accordion labeling, in a carton/box, etc.).
Hope some of this helps.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 31-Aug-2019 12:51
From: Anonymous Member
Subject: Label Adherance (Binding)
This message was posted by a user wishing to remain anonymous
Dear RAPS community,
Are there any specific FDA standards for strength of adherence/binding of a label to a package/product for OTC products?