Document ID: chunk:federal_register_of_legislation:F2025L00049:schedule:2:p10
Version: federal_register_of_legislation:F2025L00049
Segment Type: schedule
Provision Reference: sch 2 (pt 10/16)
Character Range: 144442–147390

the treatment of children under 12 years; or
 (c) in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:

          (i) ibuprofen is the only therapeutically active constituent, other than phenylephrine or when combined with an effervescent agent; and

          (ii) packed in blister or strip packaging or in a container with a child-resistant closure; and

          (iii) in a primary pack containing not more than 25 dosage units; and

          (iv) compliant with the requirements of the required advisory statements for medicine labels; and

          (v) not labelled for the treatment of children 6 years or under; and

          (vi) if combined with phenylephrine—not labelled for the treatment of children under 12 years.
INDANAZOLINE.
INDOMETACIN in preparations for external use containing 1% or less of indometacin.
IODINE:
 (a) in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose; or
 (b) in preparations for human external therapeutic use containing more than 2.5% of available iodine (excluding salts, derivatives or iodophors);
     except in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.
IPRATROPIUM in preparations for nasal use.
IRON COMPOUNDS (excluding iron oxides when present as an excipient, in divided preparations containing 10 mg or less of total iron oxides per dosage unit or in undivided preparations containing 1% or less of total iron oxides) for human internal use except:
 (a) when included in Schedule 4; or
 (b) when labelled with a recommended daily dose of 24 mg or less of iron:

          (i) in undivided preparations supplied in packs each containing 750 mg or less of iron; or

          (ii) in divided preparations:

             (A) containing more than 5 mg of iron per dosage unit in packs each containing 750 mg or less of iron; or

             (B) containing 5 mg or less of iron per dosage unit.
ISOCONAZOLE for human use in dermal preparations.
ISOPROPAMIDE in preparations for dermal use containing 2% or less of isopropamide.
KETOCONAZOLE in preparations for dermal use except:
 (a) in preparations containing 1% or less of ketoconazole for the treatment of the scalp; or
 (b) in preparations for the treatment of tinea pedis.
KETOTIFEN for ophthalmic use in preparations containing 0.025% or less of ketotifen.
LANSOPRAZOLE in oral preparations 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 7 days' supply.
LEVOCABASTINE in topical eye or nasal preparations.
LEVOCETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years