Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_254
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 254
Character Range: 145006–146821

254                                       4-(PARA-HYDROXYPHENYL)-2-BUTANONE                                                 E         4-(para-hydroxyphenyl)-2-butanone must only be included in medicines when:

                                                                                                                                      (a) in combination with other permitted ingredients as a flavour proprietary excipient formulation;

                                                                                                                                      (b) in combination with other permitted ingredients as a fragrance proprietary excipient formulation; and/or

                                                                                                                                      (c) in topical medicines for dermal application that are not intended for use in the eye or on damaged skin.

                                                                                                                                      The total concentration of flavour proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 5% of the total medicine.

                                                                                                                                      The total concentration of fragrance proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 1% of the total medicine.

                                                                                                                                      The concentration of 4-(para-hydroxyphenyl)-2-butanone in a topical medicine for dermal application must not be more than 1% of the total medicine.