Over The Counter cosmetics

Over The Counter cosmetics

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).

Get in Touch

Need a piece of advice, a quotation or answers to your questions? Contact us…

Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!

As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

  • First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
  • 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
  • A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
  • No hidden costs: Biorius does not charge you for any question, call, or meeting.
  • A best-in-class IT tool, free of charge, and saving a lot of your time.
  • More than 1,500 international clients have already chosen Biorius!
  • We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.

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