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Potassium Hydroxide as Callus remover
Hello,We received an observation from FDA regarding to our callus remover product saying that Potassium Hydroxide was used as a drug and we failed to test strength..the intention was to make this a cosmetic product. I am confused, but the observation may be because Potassium Hydroxide has a USP monograph? or our label says “Extra strength” or Professional formula?.. I will appreciate any advice. The cosmetic guide does not provide such details about this. Thank you!! -
3 Replies
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Dear Pattsi,I really appreciated your response. I see this is from EU. Since this was an observation from FDA in U.S, do you know where to find this in CFR?Thank you! -
Have you checked the use of Potassium Hydroxide as callus remover is allowed in U.S?
https://www.fda.gov/media/75758/downloadIt’s listed only for these
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1631&SearchTerm=potassium%20hydroxideHere is the Philippines FDA follow the EU
https://ww2.fda.gov.ph/attachments/article/453569/FDA%20Circular%20No.2017-006-1.pdf
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