Australian Approved Name (AAN): Nutmeg oil
Common name/s and synonyms: Myristica fragrans seed oil essential
Mandatory component: Safrole
Warning and Restrictions: When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.
When the concentration of Nutmeg oil in the medicine is more than 50%, the nominal capacity of the container must be no more than 25mL, the medicine must have a restricted flow insert fitted on the container and requires the following warning statement on the medicine label:
CHILD – Keep out of reach of children (or words to that effect).
Allowable purpose of the ingredient: Active. Excipient. Homeopathic
TGA reference: British Pharmacopoeia