Australian Approved Name (AAN): Cajuput oil
Common name/s and synonyms: Melaleuca cajuputi & M (species) leaf & twig oil ess; Oleum Cajuputi
Mandatory component: Cineole.
Warnings and Restrictions: When the concentration in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the concentration in the medicine is more than 25% and the nominal capacity of the container is more than 15 mL, a child resistant closure and restricted flow insert must be fitted on the container. When the concentration in the medicine is more than 25% and the nominal capacity of the container is less than 15 mL, a restricted flow insert must be fitted to the container.
When the concentration in the medicine is more than 25%, 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 concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL.
When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container 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 concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the medicine must have the restricted flow insert fitted on the container 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.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic
TGA reference: British Pharmaceutical Codex