U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) permits urea peroxide to be uses as an ear wax removal aid active ingredient in over-the-counter (OTC) ear drug products at concentrations up to 6.5%. It is also permitted for use in oral OTC drug products as an oral wound cleanser. When used in OTC drug products, this ingredient must be called carbamide peroxide.

Link to FDA Code of Federal Regulations for Carbamide Peroxide http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Link to FDA Federal Register for Carbamide Peroxide http://www.fda.gov/cder/otcmonographs/Oral_Health_Care/oral_health_care_…

Expert Panel for Cosmetic Ingredient Safety

The Expert Panel for Cosmetic Ingredient Safety has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the Expert Panel procedures.

The European Commission’s Scientific Committee on Consumer Products (SCCP) evaluated the safety of hydrogen peroxide in tooth whitening products. This evaluation included the use of hydrogen peroxide releasing substances such as Urea Peroxide. The SCCP concluded that use of products containing up to 1% hydrogen peroxide was safe. The SCCP also concluded that use of products containing up to 6% hydrogen peroxide could be used after consultation and approval of a dentist.

Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including urea peroxide, are listed in the Cosmetics Directive of the European Union and may be used in hair care, skin care, nail hardening, and oral hygiene products at maximum concentrations of 12%, 4%, 2%, and 0.1%, respectively, of H2O2 present or released (see Annex III). Hair care, skin care and nail hardening products containing hydrogen peroxide must be labeled: “Contains hydrogen peroxide. Avoid contact with eyes. Rinse immediately if product comes in contact with them.” Hair products containing hydrogen peroxide must recommend that gloves be worn when the product is used.

Health Canada permits the use of urea peroxide and other peroxide-generating compounds in oral products and tooth whitening systems when the appropriate information has been submitted and the product is labeled with cautionary statements. If oral products contain more than 3% hydrogen peroxide (or equivalent), evidence that the product is safe when used as directed must be submitted to the Cosmetics Division of the Consumer Product Safety Bureau.