Regulatory Context

Drug Facts serves as the labeling format and source of information for Over The Counter (OTC) products as set forth by the Food and Drug Administration (FDA) in the Federal Register of March 1999, which regulates OTC labeling rules.

Over-the-counter drugs are products available without a prescription: OTC drugs are defined by the FDA as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional”.

This format has been put in place to simplify OTC labels for consumer use and is based on readability and clarity criteria.

Drug Facts are required to be displayed on all OTC labeling materials in an easy-to-read format to help people in their OTC selection and to guide consumers in better following instructions for use (e.g., dosage, etc.).

Drug Facts Content

Information that must be included in the Drug Facts is as follows:

1. Active ingredients, including percentages in each dosage
2. Product purpose
3. Product indications
4. Any specific warnings
5. Dosage instructions
6. Inactive ingredients, as they help the consumer choose the most suitable product (to avoid allergic reactions, for example).

BIORIUS can prepare Drug Facts to be included on OTC product labels, including required information.

How does it work?

BIORIUS can help you with the following categories of OTCs:

• Acne care
• Anticaries
• Antiperspirants
• Corn/callus removers
• Dandruff care
• Oral health care
• Skin protectants
• Sunscreen

BIORIUS’ process consists of two phases: the formula review of the OTC and the preparation of the Drug Facts.

In order to proceed with the preparation of the Drug Facts, BIORIUS’ experts analyze the product composition and each of the product’s raw materials along with the product category, all specificities and labels.

Upon completion of the formula evaluation, a report is issued by our experts, which contains the following:

• Drug facts
• Mandatory information
• Warnings
• Ingredients list (active and inactive).