Document ID: chunk:federal_register_of_legislation:F2025L00049:schedule:2:p2
Version: federal_register_of_legislation:F2025L00049
Segment Type: schedule
Provision Reference: sch 2 (pt 2/16)
Character Range: 123493–126397

prevention of cardiovascular disease or for the inhibition of platelet aggregation; and

          (iii) compliant with the requirements of the required advisory statements for medicine labels.
    ASTODRIMER SODIUM when used in a nasal spray.
    ATROPA BELLADONNA (belladonna):
 (a) for external use in preparations containing 0.03% or less of total solanaceous alkaloids; or
 (b) for oral use:

          (i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

          (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
ATROPINE (excluding atropine methonitrate) for oral use:
 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
AZELAIC ACID in dermal preparations for human therapeutic use.
AZELASTINE:
 (a) in preparations for nasal use; or
 (b) in topical eye preparations containing 0.05% or less of azelastine.
BECLOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of beclometasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
BENZOCAINE in preparations for topical use other than eye drops:
 (a) containing 10% or less of total local anaesthetic substances, except in dermal preparations containing 2% or less of total local anaesthetic substances; or
 (b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
BENZOYL PEROXIDE in preparations for human external therapeutic use containing 10% or less of benzoyl peroxide except in preparations containing 5% or less of benzoyl peroxide.
BENZYDAMINE in preparations for topical use, except:
 (a) in preparations for dermal use; or
 (b) in divided topical oral preparations containing 3 mg or less of benzydamine; or
 (c) in undivided topical oral preparations containing 0.3% or less of benzydamine in a primary pack containing not more than 50 mL.
BEPHENIUM SALTS.
BIFONAZOLE in preparations for dermal use except:
 (a)