Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4619
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4619
Character Range: 2180409–2183824

4619                                      SODIUM PERBORATE                                                                         A, H      Boron is a mandatory component of sodium perborate.
                                                                                                                                             When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron.
                                                                                                                                             When used in preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%.
                                                                                                                                             When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:
                                                                                                                                             - (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or
                                                                                                                                             - (ADULT) 'Adults only' (or words to that effect).
                                                                                                                                             When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:
                                                                                                                                             - (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or
                                                                                                                                             - (ADULT) 'Adults only' (or words to that effect).
                                                                                                                                             When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
                                                                                                                                             - (BORON) 'Contains boron' (or words to that effect).
                                                                                                                                             When the medicine is for topical use for dermal application, the following warning statement is required on the label:
                                                                                                                                             - (BROKEN) 'Use on unbroken skin only' (or words to that effect).