Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3254
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3254
Character Range: 1494839–1498280

3254                                      MENTHA ARVENSIS OIL                                                                           E         Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation.
                                                                                                                                                  The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
                                                                                                                                                  Menthol is a mandatory component of Mentha arvensis oil.
                                                                                                                                                  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 statements 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.