Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_5064
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 5064
Character Range: 2357028–2358626

5064                                      TURNERA DIFFUSA                                                                          A, E, H   Beta-arbutin is a mandatory component of Turnera diffusa.
                                                                                                                                             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%.