Australian Approved Name (AAN): Cineole
Common names and synonyms: 1,3,3-Trimethyl-2-oxabicyclo[2.2.2]octane; Eucalyptol; Eucaliptol; Cajeputol; 1,8-epoxy-p-menthane; 1,8-cineole
Warnings and Restrictions: In liquid preparations when the concentration of cineole in the preparation is more than 25%:
a) the nominal capacity of the container must be no more than 25 millilitres;
b) a restricted flow insert must be fitted on the container; and
c) the container 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, 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 also have a child resistant closure.
Allowable purpose of the ingredient: Excipient
TGA reference: Martindale The Extra Pharmacopoeia