Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_927
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 927
Character Range: 449481–453186

927                                       BORAX                                                                                            A, E, H   Boron is a mandatory component of borax.
                                                                                                                                                     The percentage of boron from borax should be calculated based on the molecular weight of borax.
                                                                                                                                                     The maximum recommended daily dose must not provide more than 6mg of boron.
                                                                                                                                                     In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 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).