Australian Approved Namen (AAN): Camphor oil white
Common names and synonyms: Cinnamomum camphora whole plant (or any part) oil ess. light fraction lacking safrole
Mandatory components: Camphor 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 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. Excipient. Homeopathic
TGA reference: British Pharmaceutical Codex