Australian Approved Name (AAN): Leptospermum scoparium oil
Warnings and Restrictions: Only for use as an active ingredient when the route of administration is topical or oral application in a mouthwash preparation. If the concentration is more than 25%, the nominal capacity of the container must be no more than 25mL.
When the concentration is more than 25%, and the nominal capacity of the container less than 15mL, a restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label:
CHILD – Keep out of reach of children (or word to that effect).
NTAKEN – Not to be taken.
When the concentration is more than 25%, the nominal capacity of the container is more than 15 mL but no more than 25 mL, a child resistant closure and restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label:
CHILD – Keep out of reach of children (or word to that effect).
NTAKEN – Not to be taken.
Allowable purpose of the ingredient: Active
TGA reference: Therapeutic Goods Administration