vberkesch Posted June 12, 2011 Share Posted June 12, 2011 Hi all, I make a foot lotion bar with menthol in it at about 4%. At this % the menthol gives a wonderful cooling feeling. I know that some have said that you should not go over 3% - BUT at this % I get the cooling feeling. Is it legal to sell this OR is it a medicine with menthol in it?? Is there a certain % that I cannot go over and it will be considered a medicine?? P.S. Icy Hot has 16% menthol Vanessa Quote Link to comment Share on other sites More sharing options...
vberkesch Posted June 12, 2011 Author Share Posted June 12, 2011 I got my answer...sorry! Quote Link to comment Share on other sites More sharing options...
Lorelei Posted June 12, 2011 Share Posted June 12, 2011 I'm curious about the answer. Quote Link to comment Share on other sites More sharing options...
mychellec Posted June 14, 2011 Share Posted June 14, 2011 You can sell this as long as you are not making medical claims - ie healing, therapeutic, etc. If you make claims it is considered an OTC medication and will require FDA approval. You will want to include a warning label on this product in any case, simply telling customers to discontinue use if irritation occurs. This should cover your legal bases. Quote Link to comment Share on other sites More sharing options...
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