Monographs specify the active ingredients, levels of actives and permitted combinations of active ingredients that can be used in cosmetics that make OTC drug claims. Monographs also contain guidance on labeling and test methods to verify efficacy.
Components of the Drug Facts Label
- Active Ingredient(s) – Active ingredients and the percentage of each in the product are listed. Generally these are weight percent but there are exceptions. For example the Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products used % volume.
- Uses – Symptoms or disorders that the OTC drug is indicated for.
- Warnings – When the product should not be used, what at physician or pharmacist should be consulted, factors that may alter the expected response to the product, and common side effects.
- Directions – Dosage and frequency of use. Can be sub-dived by age group, size, or other factors that may affect response to the product.
- Other information – Special instructions as needed. For example, storage conditions to preserve the shelf life of the product.
- Inactive Ingredients – The ingredients that comprise the delivery vehicle of the product.
The appropriate test method is designated in each monograph along with details regarding laboratory validation, instrument calibration and standard materials to test against when appropriate. The final product must pass the test as described by the monograph to claim efficacy.
While monographs are lengthy and complicated, they exist to protect consumers. That’s why it is important to have a deep understanding of the monograph when working on formulating cosmetics that are also OTC drugs.
Click this link to see part one of over the counter drugs and cosmetics.