Drug Labeling and Claims

EAS’ labeling staff is highly experienced in requirements for pharmaceutical labels. With our detailed knowledge of FDA labeling requirements, we can review your label for formatting and claims and advise you on how to be in compliance.

In the case of Over the Counter Non-Prescription Drugs, or OTCs, the product must 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.

Our labeling experts guidance includes labeling of homeopathic and conventional allopathic drugs; ensure that the structure/function claims are appropriate whether your product is a drug or a dietary supplement, and identify when both cosmetic and drug claims can be included in labeling certain products.

EAS Consulting Group assist companies with the design and format of all pharmaceutical product labels. Our consultants, with both FDA and industry experience, understand the complexities of labeling regulations and ensure compliance.