OTC-regulations

FDA drug definition

A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Required sections of drug facts label

Active ingredients and amount, purpose, indications, warnings, directions, other ingo, inactivee ingredients, statement of identity, net quantity, manufactureer information, expiration date, lot code, tamper evident statement

Label

On container and box

Labeling

Other material (package insert)