Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4798
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4798
Character Range: 2248311–2250926

4798                                      SUGAR CANE WAX ALCOHOLS                                                                  A, H      The routes of administration for medicines that contain sugar cane wax alcohols must be limited to:
                                                                                                                                             (a) topical for dermal use; and
                                                                                                                                             (b) oral.
                                                                                                                                             When for use in topical medicines, the maximum recommended daily dose of the medicine must not provide more than 12 mg of sugar cane wax alcohols.
                                                                                                                                             When for oral use:
                                                                                                                                             (a) the maximum recommended daily dose of the medicine must not provide more than:
                                                                                                                                             (i) 12 mg of sugar cane wax alcohols for individuals aged less than 18 years; and
                                                                                                                                             (ii) 20 mg of sugar cane wax alcohols for individuals aged 18 years and above.
                                                                                                                                             (b) The following warning statement (or words to the same effect) is required on the medicine label:
                                                                                                                                             - (PREGNT) 'Not recommended for use by pregnant and lactating women'.
                                                                                                                                             (c) If the maximum recommended daily dose of the medicine contains 20 mg of sugar cane wax alcohols, the following warning statement is also required on the medicine label:
                                                                                                                                             - (ADULTS) 'Adults only'.