Australian approved name (AAN): Wintergreen Oil
Common name/s and synonyms: Betula lenta stem bark oil ess &/or Gaultheria procumbens leaf oil ess, Gaultheria oil
Plant part used: Stem bark and Leaf
Mandatory component/s: Methyl salicylate
Warnings and restrictions: The concentration of Methyl salicylate in the medicine must be no more than 0.001%. When the concentration of Methyl salicylate in a liquid preparation is more than 5%, and the dosage form is other than spray, the medicine requires child resistant packaging.
When the concentration of Methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging but the delivery device must be engaged into the container in such a way that prevents it from being readily removed, direct suction through the delivery device results in delivery of no more than one dosage unit, and actuation of the spray device is ergonomically difficult for young children to accomplish.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic