Australian Approved Name (AAN): Peppermint oil
Common name/s and synonyms: Mentha x piperita L. aerial parts oil ess. mint oil
Mandatory component: Menthol
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.
When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic
TGA reference: British Pharmacopoeia