Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3595
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3595
Character Range: 1687153–1688976

3595                                      ORANGE OIL BITTER                                                                             E         Orange oil bitter must only be included in medicines when in combination with other permitted ingredients as a flavour or fragrance proprietary excipient formulation.
                                                                                                                                                  The total concentration of flavour proprietary excipient formulations containing orange oil bitter must not be more than 5% of the total medicine.
                                                                                                                                                  The total concentration of fragrance proprietary excipient formulations containing orange oil bitter must not be more than 1% of the total medicine.
                                                                                                                                                  The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' or words to that effect must be included on the medicine label unless the medicine is:
                                                                                                                                                  a) for internal use;
                                                                                                                                                  b) in preparations containing 1.4% or less of orange oil bitter; or
                                                                                                                                                  c) for use in soaps or bath or shower gels that are washed off the skin.