Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3527
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3527
Character Range: 1650106–1654549

3527                                      OCIMUM KILIMANDSCHARICUM                                                                      A, H      Camphor is a mandatory component of Ocimum kilimandscharicum.
                                                                                                                                                  In solid and semi solid preparations, the concentration of camphor must not be more than 12.5%.
                                                                                                                                                  In liquid preparations, the nominal capacity of the container must not be more than 25 millilitres.
                                                                                                                                                  In liquid preparations other than essential oils or distillates, the concentration of camphor must not be more than 2.5%.
                                                                                                                                                  In essential oil or distillate preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include 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'; and
                                                                                                                                                  - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect).
                                                                                                                                                  In essential oil or distillate preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include 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'; and
                                                                                                                                                  - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect).
                                                                                                                                                  In essential oil or distillate preparations, if the concentration of camphor is more than 10%, 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 restricted flow insert and child resistant closure fitted on the container and include 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'; and
                                                                                                                                                  - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect).