Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4267
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4267
Character Range: 1982139–1986474

4267                                      RACEMIC CAMPHOR                                                                          E, H      Only for use as an active homoeopathic or excipient ingredient.
                                                                                                                                             In solid and semi solid preparations, the concentration of camphor must not be more than 12.5%.
                                                                                                                                             In liquid preparations other than essential oils, the concentration of camphor must not be more than 2.5%.
                                                                                                                                             In essential oil 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 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 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).
                                                                                                                                             If the concentration of camphor is more than 2.5%, the nominal capacity of the container must not be more than 25 millilitres.