Our complete Product Disclaimer is being finalised by counsel.
The full disclaimer will detail the regulatory status of our compounded formulations, the realistic range of outcomes, and the responsibilities shared between Zashel, your clinician, and you.
For questions about a specific formulation, please consult your clinician or write to care@zashel.com.
Compounded medicine.
Zashel formulations are compounded prescription medicines. They are prepared by a U.S. licensed compounding pharmacy, in your name, at the direction of your clinician. Compounded medicines are not commercially manufactured, mass-produced products. They are individually prepared for the patient whose prescription they fill.
What this means
- Compounded prescriptions are not FDA-approved drugs. The FDA approves manufactured drugs that are sold to a broad population — it does not approve individual compounded prescriptions, which are prepared one patient at a time.
- The active ingredients in our formulations are sourced from FDA-registered facilities and meet U.S. Pharmacopeia (USP) standards.
- We commission independent third-party laboratory testing for sterility, potency, and purity. Certificates of analysis are available on request.
What outcomes you can expect.
Hair regrowth and restoration are biological processes that vary from one woman to another. Outcomes depend on the underlying cause of hair loss, your overall health, the consistency of your protocol, and time. Some women see meaningful change in months. Others take longer. A small number do not respond to a given protocol and require adjustment.
We do not promise any specific outcome. Marketing language describing what is possible should not be read as a guarantee of what will be.
Side effects and safety.
All medicines, including compounded ones, can cause side effects. Your clinician will discuss the realistic side-effect profile of your specific protocol before prescribing. If you experience any unexpected reaction, stop your protocol and contact your clinician immediately. In an emergency, call 911 or your local emergency number.