2054. | Fluorides for human use | | (a) in
preparations for ingestion containing 0.5mg or less of fluoride ion per dosage
unit; or | | (b) in liquid preparations for topical use containing
1 000mg/kg or less of fluoride ion, in a container with a child-resistant
closure | | (i) for therapeutic use when compliant with
the requirements of the Required Advisory Statements for Medicine Labels
(September 2008) , except in preparations containing 220mg/kg or less of
fluoride ion, in packs containing not more than 120mg total fluoride, when
fitted with a child-resistant closure and compliant with the requirements of
the Required Advisory Statements for Medicine Labels ; or | | (ii) for
non-therapeutic use when labelled with warnings to the following effect:
| | (A) Do not swallow; | | (B) Do not use [this product/name of
product] in children 6 years of age or less | | except in
preparations containing 220mg/kg or less of fluoride ion, in packs containing
not more than 120mg total fluoride, when fitted with a child-resistant closure
and labelled with warnings to the following effect: | | (A) Do not swallow;
| | (B) Do not use [this product/name of product] in children 6 years of
age or less | | except in preparations containing 15mg/kg or
less of fluoride ion or preparations for supply to registered dental
professionals or by approval of an appropriate authority. |