Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3347
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3347
Character Range: 1563496–1567850

3347                                      METHYL SALICYLATE                                                                             A, E      Not to be included in medicines for use in the eye or on damaged skin.
                                                                                                                                                  When used internally, the concentration in the medicine must not be more than 0.001%.
                                                                                                                                                  When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.
                                                                                                                                                  When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if:
                                                                                                                                                  - the delivery device is engaged into the container in such a way that prevents it from being readily removed;
                                                                                                                                                  - direct suction through the delivery device results in delivery of no more than one dosage unit; and
                                                                                                                                                  - actuation of the spray device is ergonomically difficult for young children to accomplish.
                                                                                                                                                  The following warning statement is required on the medicine label:
                                                                                                                                                  - (METSAL) 'Contains methyl salicylate' (or words to that effect).
                                                                                                                                                  When for use in topical medicines for dermal application:
                                                                                                                                                  i) the concentration of methyl salicylate in the medicine must not be more than 25%;
                                                                                                                                                  ii) the following warning statements are required on the medicine label:
                                                                                                                                                  - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);
                                                                                                                                                  - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';
                                                                                                                                                  - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect);
                                                                                                                                                  - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);
                                                                                                                                                  iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:
                                                                                                                                                  - (IRRIT) 'If irritation develops, discontinue use'.