Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_748
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 748
Character Range: 340822–342675

748                                       AZADIRACHTA INDICA                                                                A, H      The ingredient can only be derived from the plant part seed and must be cold pressed or debitterised oil.

                                                                                                                                      "Debitterised neem seed oil" means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.

                                                                                                                                      Cold pressed Azadirachta indica seed oil must be for topical use for dermal application only.

                                                                                                                                      When the concentration of cold pressed Azadirachta indica seed oil is more than 1%, a child resistant closure must be fitted to the container.

                                                                                                                                      The medicine requires the following warning statements on the medicine label:

                                                                                                                                      - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect).'

                                                                                                                                      - (NTAKEN) 'Not to be taken (or words to that effect).'

                                                                                                                                      - (CHILD) 'Keep out of reach of children (or words to that effect).'