Spearmint oil 393 views0 applications

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

Apply for this resource
Share this resource