Australian approved name (AAN): Cinnamomum camphora
Common names and synonyms: Camphor tree
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 or distillates, the concentration of camphor must be no more than 2.5%.
In essential oil preparations or distillates and the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres and the following warning statements must be included on the medicine label:
CHILD – Keep out of reach of children (or words to that effect);
NTAKEN – Not to be taken.
Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist.
In essential oil preparations or distillates, 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. In essential oil preparations or distillates, 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. In essential oil preparations or distillates, 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.
In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% the nominal capacity of the container must be no more than 25 millilitres and the medicine must 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 liquid preparations other than essential oils or distillates, 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. In liquid preparations other than essential oils or distillates, 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 a restricted flow insert fitted on the container.
When for internal use then the concentration of safrole in a medicine must be no more than 0.1%. When for uses other than internal use, the concentration of safrole in a medicine must be no more than 1.0%. When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic
TGA Reference: British Pharmacopoeia