Australian Approved Name (AAN): Propolis tincture
Mandatory component: Lead
Warnings and Restrictions: The concentration of lead in the medicine must be no more than 0.001%.
When used topically, the medicine requires the following warning statement on the medicine label:
PROP1 – WARNING: Propolis may cause skin irritation, test before use.
When used for other than for topical, the medicine requires the following warning statement on the medicine label:
PROP2 – WARNING: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.
Allowable purpose of the ingredient: Active. Excipient