Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_5268
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 5268
Character Range: 2431160–2432464

5268                                      ZINC SULFATE MONOHYDRATE                       A, E, H   When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%.
                                                                                                   When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate.
                                                                                                   When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
                                                                                                   When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
                                                                                                   - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR
                                                                                                   - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'