Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3512
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3512
Character Range: 1636844–1641636

3512                                      NYCTANTHES ARBOR-TRISTIS                                                                      A, H      When the plant part is leaf:
                                                                                                                                                  a) methyl salicylate is a mandatory component of Nyctanthes arbor-tristis;
                                                                                                                                                  b) not to be included in medicines for use in the eye or on damaged skin;
                                                                                                                                                  c) when used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%;
                                                                                                                                                  d) 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;
                                                                                                                                                  e) 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;
                                                                                                                                                  f) the following warning statement is required on the medicine label:
                                                                                                                                                  - (METSAL) 'Contains methyl salicylate' (or words to that effect); and
                                                                                                                                                  g) 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'.