All,
When an OTC monograph does not specify a lower age limit (e.g. the monographs for wart removers or ophthalmic lubricants) is there a default age below which the product is not considered appropriate for use? Or should that be taken to mean the product is safe for all ages?
This seems basic, but I couldn't find a clear answer in the CFR or on the FDA website.
Thank you in advance for your thoughts.
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Vincent A.
Regulatory Affairs Manager
Tarrytown NY
United States
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