Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2148
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2148
Character Range: 1026902–1029335

2148                                      EUGENOL                                                                                          E         When for oral ingestion, eugenol must not comprise more than 0.06% of the formulation.
                                                                                                                                                     When used in topical medicines for dermal application, the following apply:
                                                                                                                                                     a) When the concentration of Eugenol in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.
                                                                                                                                                     b) When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label:
                                                                                                                                                     - (CHILD) 'Keep out of reach of children' (or words to that effect)
                                                                                                                                                     - (NTAKEN) 'Not to be taken'
                                                                                                                                                     c) When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15mL, a restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label:
                                                                                                                                                     - (CHILD) 'Keep out of reach of children' (or words to that effect)
                                                                                                                                                     - (NTAKEN) 'Not to be taken'