Document ID: chunk:federal_register_of_legislation:F2025L00049:schedule:3:p3
Version: federal_register_of_legislation:F2025L00049
Segment Type: schedule
Provision Reference: sch 3 (pt 3/8)
Character Range: 165872–168825

treatment of children under 2 years of age.
ECONAZOLE in preparations for vaginal use.
ELETRIPTAN for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well‑established pattern of symptoms.
ERYTHRITYL TETRANITRATE for therapeutic use.
FAMCICLOVIR for oral use, in divided preparations containing a total dose of 1500 mg or less of famciclovir for the treatment of herpes labialis (cold sores).
FLAVOXATE.
FLUCONAZOLE in single‑dose oral preparations containing 150 mg or less of fluconazole for the treatment of vaginal candidiasis.
FLUORIDES for human topical use:
 (a) in liquid preparations containing 5500 mg/kg or less of fluoride ion, in a container with a child‑resistant closure except when included in or expressly excluded from Schedule 2; or
 (b) in non‑liquid preparations containing 5500 mg/kg or less of fluoride ion except:

          (i) in preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, compliant with the requirements of the required advisory statements for medicine labels; or

          (ii) in preparations for non‑therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings to the following effect:

             (A) Do not swallow; and

             (B) Do not use [this product/name of product] in children six years of age or less; or

          (iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority.
GLUCAGON.
GLYCERYL TRINITRATE:
 (a) in preparations for oral use; or
 (b) in preparations for rectal use.
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1% or less of hydrocortisone:
 (a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
 (b) for dermal use, in packs containing 2 g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) in adults and adolescents (12 years of age and older); or
 (c) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:

          (i) in undivided preparations, in packs of 35 g or less; or

          (ii) in packs containing 12 or less suppositories;
 except when included in Schedule 2.
HYOSCINE BUTYLBROMIDE in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide when labelled for adults and children 6 years and over.
IBUPROFEN when:
 (a) either: