Ever gone on vacation and looked for sunscreen? Looking for a diaper cream for your baby with diaper cream. You have probably noticed the over-the-counter (OTC) Drug Facts Label on these two products as well as over 100,000 other OTC products.
Per the FDA. “In the Federal Register of March 1999, the Food and Drug Administration published the OTC Drug Facts Label regulation. This regulation required most OTC drug products to comply with the new format and content requirements by May 2002. Manufacturers may continue to use old-format labels until their inventories are exhausted.”
OTC Drug Facts Labels must contain the following information in this order:
- The active ingredient including the % in the dosage
- Purpose
- Use
- Warnings
- Directions
- The inactive ingredients
ProductVision’s well-established Drug Facts Module is based upon FDA labeling requirements set forth in 21 CFR 201.66 – Format and content requirements for over-the-counter (OTC) drug product labeling and other related §201 requirements for labeling over-the-counter drugs and drug-cosmetics. Within ProductVision, Code of Federal Regulations Title 21 labeling requirements (Property validation entries, and Instruction Memos) have already been created for Anti-Fungal, Acne, Antiperspirants, and Sunscreens Monographs. However, the system can easily be extended for other Monographs as additional needs arise. The Drug Facts Module allows you to easily assign Drug Facts statements to formulas. Along with calculated property values, generating the OTC Drug Facts Label is very easy and efficient. For more information about the Drug Facts Module and how your company can save time and money generating Drug Facts labels, contact your ProductVision Support representative.
For more information regarding OTC Drug Facts Label: https://www.fda.gov/drugs/drug-information-consumers/otc-drug-facts-label
The ProductVision® product development software is a product lifecycle management (PLM) system that manages all aspects of the product development process. Suitable for industries including paint & coatings, personal care and food & beverage, ProductVision’s comprehensive list of modules includes Formula Management, Regulatory, GHS, Project Management, Document Management, Ingredient Labelling, Guidelines & Restrictions, Sample Tracking, Testing and Workflow. We have your complete development process covered no matter what your industry.