Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_5112
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 5112
Character Range: 2370137–2371447

5112                                      VACCINIUM VITIS-IDAEA                          A, H      Beta-arbutin is a mandatory component of Vaccinium vitis-idaea.
                                                                                                   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%.