They must be harmless in the amounts used, their presence must not affect the bioavailability, therapeutic efficacy or safety of the medicinal ingredients and they must not interfere with assays and tests for the medicinal ingredients and, if present, antimicrobial preservatives. Herbal ingredients are not permitted except as fragrance or flavour components. Other requirements described in the Regulations to the Food and Drugs Act and in the Guide for the Labelling of Drugs for Human Use must also be met. Other permitted statements Endorsements of professional dental associations may be used on the labels provided that the Association has accepted its use and the statement is not in contravention of the Food and Drugs Act and Regulations. If the product is to be diluted before use, the appropriate dilution directions must be present, and the potency of the product after dilution clearly indicated.
Warnings Keep out of the reach of children.
These cautionary statements shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour. The Pharmacological Basis of Therapeutics , 8th Edition, Pergamon Press, 1990. Remington's Pharmaceutical Sciences , 18th Edition, Mack Publishing Co., 1990. Department of National Health and Welfare, Food and Drugs Act and Regulations.