ISO 16408:2004 specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as manufacturer' s instructions for use, marking and/ or labelling requirements.
ISO 16408:2004 is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
ISO 16408:2004 is not applicable to oral rinses available by prescription only.