Australian approved name (AAN): Betula nigra
Common names and synonyms: Black birch Red birch; River birch
Mandatory Components: Cresol, eugenol and methyl salicylate
Warnings and restrictions: For external use only when the total concentration of cresols, xylenols and other phenol homologues in the medicine is greater than 3%.
When for internal use, the concentration of eugenol in the medicine must not exceed 0.06%.
When the concentration of eugenol in the medicine is more than 25%:
a) the nominal capacity of the container must be no more than 25 mL;
b) the medicine must be fitted with a restricted flow insert;
c) when the nominal capacity of the container is more than 15 mL, the medicine must be fitted with a child resistant closure; and
d) the medicine requires 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.
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. Homeopathic.