Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4693
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4693
Character Range: 2206897–2209768

4693                                      SPEARMINT OIL                                                                            A, E, H   Menthol is a mandatory component of spearmint 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 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.