Australian Approved Name (AAN): Melaleuca oil
Common name/s and synonyms: Melaleuca alternifolia, M dissitiflora, M linariifolia & M (species) leaf & twig oil; Tea Tree oil
Mandatory components: Cineole and cajuput oil
Warnings and Restrictions:When the plant preparation is oil and the concentration in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL and the medicine requires the following warning statements on the medicine label:
CHILD – Keep out of reach of children (or word to that effect).
NTAKEN – Not to be taken.
When the nominal capacity of the container is 15 mL or less, then a restricted flow insert must be fitted on the container. Where the nominal capacity of the container is more than 15 mL but less than or equal to 25 mL, then a child resistant closure and restricted flow insert must be fitted on the container.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic
TGA reference: European Pharmacopoeia (modified); Therapeutic Goods Administration