Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3465
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3465
Character Range: 1612411–1614559

3465                                      NEOHESPERIDIN-DIHYDROCHALCONE                                                                 E         The routes of administration for medicines that contain neohesperidin-dihydrochalcone must be limited to:
                                                                                                                                                  (a) topical for dermal application; and
                                                                                                                                                  (b) oral.
                                                                                                                                                  When used in topical medicines for dermal application:
                                                                                                                                                  (a) neohesperidin-dihydrochalcone must not be included in medicines intended for use in the eye or on damaged skin; and
                                                                                                                                                  (b) the concentration of neohesperidin-dihydrochalcone in the medicine must not be more than 0.1%.
                                                                                                                                                  When used in oral medicines:
                                                                                                                                                  (a) the concentration in the medicine must not be more than 0.1%; and
                                                                                                                                                  (b) the following warning statement (or words to that effect) is required on the medicine label:
                                                                                                                                                  - (NTAKEN3) 'Not to be taken by children under 3 years old'.