Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1500
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1500
Character Range: 725008–726382

1500                                      COCAMIDOPROPYL BETAINE                                                                           E         Only for topical, mucous membrane (buccal mucosa) and dental use and not to be included in topical medicines intended for use in the eye.
                                                                                                                                                     The concentration in the medicine must be:
                                                                                                                                                     a) no more than 1% in leave on medicines
                                                                                                                                                     b) no more than 15% in wash on /wash off medicines
                                                                                                                                                     c) 1.2% for buccal mucosa and dental medicines.
                                                                                                                                                     Levels of impurities 3-dimethylaminopropylamine (DMAPA) and amidoamine (dimethylaminopropylcocoamide; AA) must be controlled to below the level of detection.