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  • FDA regulations about sanitizer

    Posted by Marit on July 29, 2020 at 5:17 pm
    In considering putting a hand-sanitizer on the market I saw that the FDA’s regulations have made an “exception” during the pandemic, but that to be in that category you can’t put essential oils or any fragrance materials in it.
    However I do want to include EO’s - so does anyone know whether I need to get an ID/FTIR test for each ingredient? I assume it falls under OTC regulations - are there are particular guidelines for labeling? I see that a lot of people are putting sanitizers with scent on the market right now, but I still want to be sure I am following the FDA rules.
    Marit replied 3 years, 6 months ago 3 Members · 3 Replies
  • 3 Replies
  • EVchem

    Member
    July 30, 2020 at 1:24 pm

    You would have to follow the standard OTC rules if you want to deviate from the temporary compounding. So registration, manufacturing in FDA registered facility, testing, etc.

  • chemicalmatt

    Member
    July 30, 2020 at 3:57 pm

    Marit, all those folks are fooling themselves into thinking their products are legit, or they are just gaming the system while they can. EV told you right: read up on 21CFR, follow the monograph for SDA and register with FDA. You need only assay the ethanol to validate, and GC with flame ionization detector does that easily as does a density meter if you know how.

  • Marit

    Member
    August 3, 2020 at 4:36 pm

    Thank you for the input :)

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