Hydrogen peroxide is a chemical commonly used for many purposes, including as a local preservative and bleach. The United States Food and Drug Administration (FDA) regulates hydrogen peroxide as an over-the-counter (OTC) drug.
The main provisions of FDA regulations on hydrogen peroxide include:
Label requirements: hydrogen peroxide products must contain appropriate warnings and instructions on the label. This information must be highlighted and easy to understand.
Strength and concentration: The strength and concentration of hydrogen peroxide must be within the limits specified by FDA, and the product must be produced in accordance with good manufacturing practice.
Quality control: hydrogen peroxide products must be regularly tested to ensure that they meet the required standards of quality, purity and efficacy.
Adverse event report: The company must report any adverse event or serious side effect related to the use of hydrogen peroxide to FDA.
Packaging requirements: hydrogen peroxide products must be packaged in a way that can protect products from pollution and protect users from injury.