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Specializing in FDA Regulatory Matters

Labeling OTC Products

The FDA requires that the drug information of an OTC product be presented using the standardized Drug Facts format and content layout which allows consumers to better read and understand how to safely and effectively use the product.

These requirements are applicable to all OTC drug (including homeopathic) and OTC drug ­cosmetic products, whether marketed under an OTC drug monograph or an application.

In addition, there are labeling regulations pertaining to:

  • Content and format of the principal display panel
  • General statements and/or warnings that must appear on all OTC products
  • Warnings or directions on products with specified ingredients
  • Tamper-Evident features and statements

Aside from FDA requirements, other governmental agencies also have regulations that may impact an OTC product label: These are:

  • Consumer Product Safety Commission
  • Customs and Border Patrol
  • Federal Trade Commission

EAS Consulting Group can assist companies with the design and format of OTC product labels. Our consultants, with both FDA and industry experience, understand the complexities of the OTC drug labeling regulations and can apply their knowledge and expertise to ensure compliance.