Australian Approved Name (AAN): Spearmint oil
Common name/s and synonyms: Mentha X cardiaca & M spicata herb fl. Oi
Mandatory component: Menthol
Maximum daily dose: 1 gram of menthol (when for internal use)
Warnings and Restrictions: When the medicine is for topical use for dermal application:
(i) the medicine must not be intended for use in the eye or on damaged skin;
(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;
(iii) the following warning statement is required on the medicine label:
EYE – Avoid contact with eyes (or words to that effect).
(iv) 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.
(v) 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.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic
TGA reference: British Pharmacopoeia