Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4316
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4316
Character Range: 2029089–2030696

4316                                      RHODODENDRON FERRUGINEUM                                                                 A, H      Beta-arbutin is a mandatory component of Rhododendron ferrugineum.
                                                                                                                                             When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
                                                                                                                                             When for dermal application exclusively to the face:
                                                                                                                                             a) the concentration of beta-arbutin in the medicine must not be more than 7%;
                                                                                                                                             b) hydroquinone is a mandatory component; and
                                                                                                                                             c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
                                                                                                                                             When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.