Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4575
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4575
Character Range: 2158774–2160667

4575                                      SODIUM CHONDROITIN SULFATE                                                               A, E      When used as an excipient ingredient:
                                                                                                                                             a) only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye;
                                                                                                                                             b) the concentration in the medicine must not be more than 0.001%.
                                                                                                                                             When used as an active ingredient:
                                                                                                                                             a) the route of administration must only be oral;
                                                                                                                                             b) the maximum daily dose must not provide more than 1,200 mg of sodium chondroitin sulfate;
                                                                                                                                             c) the following statements must be included on the medicine label:
                                                                                                                                             - (ADULT) 'Adults only' (or words to that effect);
                                                                                                                                             - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect).