Hydrogel eye patches are classified as cosmetics in the US, not drugs, so pre-market FDA approval is not required. However, under MoCRA (Modernization of Cosmetics Regulation Act), facility registration and product listing are now mandatory for most brands. Manufacturers on the AJ Cosmo Labs platform can provide MoCRA-ready documentation to support your compliance.
Read the full guide on private label hydrogel eye patch manufacturer low moq →