• Formulating

  Are products with Minoxdil always considered an OTC?

  Posted by Stell on April 10, 2024 at 7:13 am

  Hello! Our lab recently received a request to formulate a shampoo that contains Minoxdil, however, we are not an OTC manufacturer. Are all products that contain Minoxidil considered OTC? The shampoo is being advertised as just a shampoo that contains Minoxidil with no hair growth claims.

  Stell replied 7 months, 2 weeks ago 3 Members · 3 Replies

  • claims
  • hair growth
  • minoxidil
  • otc
  • shampoo
• 3 Replies

• 

  Microformulation

  Member

  April 10, 2024 at 7:14 am

  Yes, there are numerous FDA Enforcement Letters that were issued for non-compliance with Minoxidil and the OTC Monographs.

• 

  Perry44

  Administrator

  April 10, 2024 at 8:18 am

  Agree with @Microformulation - Minoxidil is a drug whether you make claims about it or not. You need to be certified to make products with it.

  • 

    Stell

    Member

    April 10, 2024 at 9:09 am

    Thank you both! That’s what I was thinking as well, but I had some team members that were insistent on it being the same as any other active.

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