Federal Drug Administration Approved OTC Pharmaceutical

 

At Faeve, formulation begins with responsibility.

For OTC products, we begin within established regulatory frameworks. The active ingredient is determined by the applicable FDA monograph, ensuring that safety, concentration limits, and labeling requirements are defined from the start. This regulatory foundation anchors every decision that follows.

From there, we expand thoughtfully. We review a broad universe of botanicals traditionally associated with the intended application. Through literature review, historical documentation, and published research, that list is carefully narrowed. Each candidate ingredient is evaluated for documented use, safety profile, and compatibility within topical formulation.

Collaboration follows. We consult phytochemical expertise to assess constituent compatibility, dermal limits, stability, and potential synergy. Botanical chemistry must support both integrity and balance.

Practical standards are equally important. We evaluate sourcing reliability, sustainability, global availability, and batch consistency before an ingredient advances further. If it cannot be sourced responsibly or produced consistently, it does not move forward.

Every formulation is then reviewed again for regulatory alignment. Claims, concentrations, and ingredient roles are assessed to ensure compliance within applicable OTC guidelines. If an ingredient creates ambiguity or exceeds safety thresholds, it is removed or reformulated.

Intuition may inspire a plant’s inclusion, but it is structure that earns its place.

When someone applies a Faeve product, we understand they may be navigating physical discomfort, emotional fatigue, or simply seeking relief they can trust. Our responsibility is to meet that moment with care — not exaggeration. We believe the earth offers powerful botanicals, but it is our role to guide them safely, respectfully, and within clear scientific and regulatory boundaries.

Each ingredient is selected with discernment. Each batch is evaluated before production. Each formulation reflects a balance of heritage, chemistry, and compliance.

At Faeve, responsibility means honoring both the person using the product and the standards that protect them.

Kevo-Prophen National Drug Code Number: