Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1038
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1038
Character Range: 504575–505825

1038                                      C17-18 ISOPARAFFIN                                                                               E         C17-18 isoparaffin must only be included in topical medicines:
                                                                                                                                                     (a) for dermal application; and
                                                                                                                                                     (b) where the dosage form of the medicine is not spray.
                                                                                                                                                     The total concentration of C15-16 isoparaffin and C17-18 isoparaffin in the medicine must not be more than 50%.
                                                                                                                                                     When the nominal capacity of the container is more than 2 mL and the medicine is not a solid or semi-solid preparation, the total concentration of designated solvents (including C17-18 isoparaffin) in the medicine must not be more than 25%.