Natural Health Products Regulations

93 (1) Subject to section 94, the inner and outer labels shall show the following information in respect of a natural health product:

• (a) on the principal display panel,

  • (i) a brand name,

  • (ii) its product number,

  • (iii) its dosage form,

  • (iv) if it is sterile, the words “sterile” and “stérile”, and

  • (v) the net amount in the immediate container in terms of weight, measure or number; and

• (b) on any panel,

  • (i) the name and address of the product licence holder,

  • (ii) if it is imported, the name and address of the importer,

  • (iii) the common name of each medicinal ingredient that it contains,

  • (iv) the proper name of each medicinal ingredient it contains, but only if the proper name is not the chemical name,

  • (v) a list by proper name, or by common name if the proper name is the chemical name, that sets out the quantity of each medicinal ingredient per dosage unit and, if any, the authorized potency of that medicinal ingredient,

  • (vi) its recommended use or purpose,

  • (vii) its recommended route of administration,

  • (viii) its recommended dose,

  • (ix) its recommended duration of use, if any,

  • (x) its risk information including any cautions, warnings, contra-indications or known adverse reactions associated with its use,

  • (xi) its recommended storage conditions, if any,

  • (xii) its lot number,

  • (xiii) its expiry date, and

  • (xiv) a description of the source material of each medicinal ingredient that it contains.

(2) In addition to the requirements set out in subsection (1), the outer label shall show

• (a) a qualitative list by common name, preceded by the words “non-medicinal ingredients”, of all non-medicinal ingredients of the natural health product; and

• (b) if the natural health product contains mercury or any of its salts or derivatives as a non-medicinal ingredient, a statement that sets out the quantity of mercury contained in the natural health product.