Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3256
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3256
Character Range: 1501215–1506154

3256                                      MENTHA PULEGIUM                                                                               A, H      D-pulegone, menthol and volatile oil components (of Mentha pulegium) are mandatory components of Mentha pulegium.
                                                                                                                                                  When the nominal capacity of the container is more than 15 millilitres, 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 15 millilitres 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:
                                                                                                                                                  - (NTAKEN) 'Not to be taken';
                                                                                                                                                  - (CHILD) 'Keep out of reach of children' (or words to that effect).
                                                                                                                                                  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.