Human prescription drug and biological product labeling including prescribing information, patient labeling, and carton and container labeling:

• Drug products
• Therapeutic biologics and monoclonal antibodies
• Vaccines

Other biological products (e.g., blood products, allergenics, cellular therapy)
Human over-the-counter (OTC) labeling:
Approved drugs
Products marketed under the monograph system
Unapproved homeopathic prescription and homeopathic OTC products
Animal prescription and animal OTC product labeling
Other types of labeling:

• Medical devices
• Dietary supplements
• Cosmetics
• Medical foods

Prescribing information for approved human prescription drug and biological products contains a summary of the essential scientific information needed for the safe and effective use of the product. It includes indications, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, information about use in specific populations, and other important information for healthcare providers9. Associated patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use)are directed to the patient, family, or caregiver. Associated container and carton labeling communicate information that is critical to the safe use of a medication from the initial prescription, to procurement, to preparation and dispensing of the product, to the time it is given to the patient.

Labeling for approved OTC drugs and OTC drugs under the monograph system is called Drug Facts. Drug Facts includes information about the purpose and use of the drug, warnings, directions for use, and other information.

Homeopathic prescription and homeopathic OTC drugs are not approved by the FDA but are allowed to be marketed. There are minimal labeling requirements for these unapproved products.