Australian approved name (AAN): Azadirachta indica
Common names and synonyms: Melia azadirachta; Neem
Plant part used: Seed
Warnings and restrictions: The ingredient can only be derived from the plant part seed and must be cold pressed or debitterised oil. “Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.
Cold pressed Azadirachta indica seed oil must be for topical use for dermal application only.
When the concentration of cold pressed Azadirachta indica seed oil is more than 1%, a child resistant closure and restricted flow insert must be fitted to the container.
The medicine requires the following warning statements on the medicine label:
PREGNT2 – Do not use if pregnant or likely to become pregnant (or words to that effect)
NTAKEN – Not to be taken (or words to that effect)
CHILD – Keep out of reach of children (or words to that effect)
Allowable purpose of the ingredient: Active. Homeopathic