Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3529
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3529
Character Range: 1654690–1656827

3529                                      OCIMUM TENUIFLORUM                                                                            A, H      When the plant part is oil or distillate, eugenol is a mandatory component of Ocimum tenuiflorum.
                                                                                                                                                  When the concentration of eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included on the medicine label:
                                                                                                                                                  - (CHILD) 'Keep out of reach of children' (or words to that effect); and
                                                                                                                                                  - (NTAKEN) 'Not to be taken'.
                                                                                                                                                  When the concentration of eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.
                                                                                                                                                  When the concentration of eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container.
                                                                                                                                                  When the preparation is for topical use in the mouth, the preparation may not contain more than 5 mL of eugenol and the concentration of eugenol in the product must not be greater than 25%.