The Medicines (Contact Lens Fluids and Other Substances) (Labelling) Regulations 1979

Additional particulars required for contact lens substances

6.—(1) Subject to the provisions of paragraph (3) and of regulation 7, in addition to the particulars specified in regulation 5, the particulars specified in paragraph (2) shall be shown either on a label on the container in which any contact lens substance is contained or on a label on the package in which the container is immediately enclosed or in a leaflet which is supplied or intended to be supplied with such substance.

(2) The particulars specified for the purposes of paragraph (1) in relation to any contact lens substance are—

(a) the date after which it is recommended that the substance should no longer be used;

(b) a recommended period within which the substance should be used after the container containing it has first been opened;

(c) directions as to how the substance is to be used;

(d) a warning in capital letters, “DO NOT MIX WITH OTHER FLUIDS EXCEPT AS DIRECTED”; and

(e) a warning that the substance should not be administered to the eye concurrently with any eye medicament except on the advice of a doctor.

(3) Where any contact lens substance is or is to be sold or supplied in solid form as a powder or tablets—

(a) instructions as to how it is to be prepared for use, including a warning that only recommended fluids should be used for dissolving the substance for administration, shall be included in the particulars;

(b) the particulars specified in paragraph (2)(c) and (e) shall be so expressed as to relate to the substance in the liquid form in which it is to be administered; and

(c) an explanation shall accompany the warning set out in paragraph (2)(d) that the warning relates to the substance in the liquid form in which it is to be administered.