Does my eczema skincare product need FDA approval?

If your product makes therapeutic claims such as 'treats eczema' or 'relieves itch caused by eczema,' it may be regulated as an OTC drug under an FDA monograph, most commonly the Skin Protectant monograph covering colloidal oatmeal. Purely cosmetic claims like 'moisturizes dry, sensitive skin' do not require pre-market approval. A cosmetic chemist with regulatory experience — the kind you can find through AJ Cosmo Labs — can help you navigate claim language to stay compliant.