Activated Resorcinol Usage Rate in Leave-on Formulation and FDA Registration

Based on the product information for Activated Resorcinol™ (4-Butyl Resorcinol), the recommended usage rate for leave-on products such as creams or gels is not more than 1%. For wash-off products like soaps, the rate is not more than 2%.

Therefore, using Activated Resorcinol™ at a concentration of 1.5-2% in a leave-on formulation would exceed the recommended rate for this product type (which should not exceed 1%).

The recommended usage rates often align with safety requirements and regulations from governing bodies like the FDA. Using an ingredient at a concentration higher than recommended, especially in leave-on products, may cause issues with registration with the Food and Drug Administration (FDA) of Thailand, as it might be considered non-compliant with safety requirements or stated limitations.

Conclusion:

Using Activated Resorcinol™ at a concentration of 1.5-2% in a leave-on formulation is likely to exceed the maximum permitted rate for this product type according to the product information, which could result in issues with FDA registration. It is advisable to consider reducing the concentration to not more than 1% for leave-on formulations or consult the latest regulations directly with the FDA for the most accurate information.