Australian Approved Name (AAN): Camphor oil brown
Common names and synonyms: Cinnamomum camphora whole plant (or any part) oil ess. heavy fraction including safrole
Mandatory components: Camphor, cineole and safrole.
Warnings and Restrictions: In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must be no 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.
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.
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.
When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres.
When the concentration of cineole in the preparation is more than 25% 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 child resistant closure and 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.
When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have the 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.
When for internal use then the concentration of safrole in a medicine must be no more than 0.1%. When for topical use then the concentration of safrole in a medicine must be no more than 1.0%. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25mL.
Allowable purpose of the ingredient: Active. Homeopathic
TGA reference: British Pharmaceutical Codex