Calmoseptine ointment is approved by the FDA for use as a skin protectant drug.

The FDA defines a skin protectant drug product as a product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may provide relief to such surfaces.(FR Doc 03-13751/347.3 June 4, 2004)



Calmoseptine Ointment is not approved for use in deep injury or puncture wounds.