Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_801
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 801
Character Range: 371466–373349

801                                       BENZALKONIUM CHLORIDE                                                                            E         Only for use in topical medicines for dermal application and nasal sprays.
                                                                                                                                                     When benzalkonium chloride is used in a topical medicine for dermal application, the concentration in the medicine must not be more than 5%.
                                                                                                                                                     When benzalkonium chloride is used in a nasal spray dosage form, the concentration of benzalkonium chloride in the medicine must not be more than 0.03%.
                                                                                                                                                     When benzalkonium chloride is used in a nasal spray dosage form which is either:
                                                                                                                                                     (i) indicated for use in children; or
                                                                                                                                                     (ii) not specifically indicated for adults only;
                                                                                                                                                     the following warning statement is required on the medicine label:
                                                                                                                                                     - (NTAKEN2) 'Not to be used by children under 2 years old' (or words to that effect).