Australian Approved Name (AAN): Mentha pulegium
Common names and synonyms: Pennyroyal
Mandatory components: D-pulegone, menthol and volatile components
Warnings and Restrictions: When the nominal capacity of the container is more than 15mL, the concentration of d-pulegone in the medicine must be no more than 4%.
When the concentration of d-pulegone in the preparation is more than 4% and the nominal capacity of the container is 15mL or less, the medicine must have a child resistant closure and restricted flow insert fitted on the container.
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.
When the medicine is for topical use for dermal application:
a) the maximum recommended daily dose must not contain more than 150 mg of Mentha pulegium oil or distillate;
b) the medicine must not be intended for use in the eye or on damaged skin;
c) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;
d) the following warning statement is required on the medicine label:
EYE – Avoid contact with eyes (or words to that effect).
e) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:
SKTEST – If you have sensitive skin, test this product on a small area of skin before applying it to a large area.
IRRIT – If irritation develops, discontinue use.
f) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:
MENTH – Contains a high concentration of menthol, which can cause severe skin irritation.
When the medicine is for internal use:
a) the maximum recommended daily dose must not contain more than 50 mg of Mentha pulegium oil or distillate;
b) the maximum recommended daily dose must not contain more than 1 gram of menthol.
Allowable purpose of the ingredient: Active. Homeopathic