Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4827
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4827
Character Range: 2259593–2261684

4827                                      SYZYGIUM AROMATICUM                                                                      A, E, H   When the plant preparation is oil or distillate and the concentration of this oil or distillate in the product is greater than 25%, the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label:
                                                                                                                                             - (CHILD) 'Keep out of reach of children' (or words to that effect); and
                                                                                                                                             - (NTAKEN) 'Not to be taken'.
                                                                                                                                             When the plant preparation is oil or distillate, the concentration of this oil or distillate in the medicine is greater than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, a child resistant closure and restricted flow insert must be fitted on the container.
                                                                                                                                             When the plant preparation is oil or distillate, the concentration of oil or distillate in the product is greater than 25% and the nominal capacity of the container is less than 15 millilitres, a restricted flow insert must be fitted on the container.
                                                                                                                                             When the plant preparation is oil or distillate and the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of the oil or distillate and the concentration of oil or distillate in the product must not be greater than 25%.