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: Not to be included in medicines for use in the eye or on damaged skin.
When used internally, the concentration of methyl salicylate in the medicine must not be 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 if:
– the delivery device is 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.
The following warning statement is required on the medicine label:
METSAL – Contains methyl salicylate (or words to that effect).
When for use in topical medicines for dermal application:
i) the concentration of methyl salicylate in the medicine must not be more than 25%;
ii) the following warning statements are required on the medicine label:
PREGNT2 – Do not use if pregnant or likely to become pregnant (or words to that effect).
CHILD4 – Do not use [this product/insert name of product] in children 6 years of age or less.
SENS – Application to skin may increase sensitivity to sunlight (or words to that effect).
AVOID – Avoid prolonged exposure in the sun (or words to that effect).
iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:
IRRIT – If irritation develops, discontinue use.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic