Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3605
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3605
Character Range: 1694662–1697440

3605                                      ORIGANUM MAJORANA                                                                             A, H      Beta-arbutin is a mandatory component of Origanum majorana.
                                                                                                                                                  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%.
                                                                                                                                                  When the plant preparation is oil or distillate, and the concentration of Origanum majorana oil or distillate within the medicine is more than 50%:
                                                                                                                                                  a) the nominal capacity of the container must not be more than 50 mL;
                                                                                                                                                  b) a restricted flow insert must be fitted on the container; and
                                                                                                                                                  c) the following warning statement is required on the label:
                                                                                                                                                  - (CHILD) 'Keep out of reach of children' (or words to that effect).