Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4587
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4587
Character Range: 2163398–2165376

4587                                      SODIUM FLUORIDE                                                                          A, E, H   Fluoride is a mandatory component of sodium fluoride.
                                                                                                                                             The route of administration must be limited to dental.
                                                                                                                                             The dosage form must be limited to pastes, powders and/or gels for dental hygiene.
                                                                                                                                             When used as an active ingredient, the medicine is subject to the following conditions:
                                                                                                                                             (a) only for use in combination with at least one other active ingredient; and
                                                                                                                                             (b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg.
                                                                                                                                             When the concentration of fluoride ion is more than 1000 mg/kg, the medicine requires the following statements on the medicine label:
                                                                                                                                             - (DNTSW) 'Do not swallow.'
                                                                                                                                             - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.'