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

5.  (1)  Subject to the provisions of paragraph (2), the particulars specified for the purposes of regulation 4 in relation to any contact lens substance are—

(a)the number of any product licence which relates to such substance;

(b)the batch reference given by the person who manufactured such substance to the batch of which it forms a part;

(c)the name of such substance or an appropriate description thereof;

(d)the purpose or purposes for which such substance is to be used and in particular, if it is to be used for cleaning, disinfecting, irrigating, lubricating, wetting, soaking or rinsing a contact lens or blank or as a barrier between such lens or blank and the human eyeball, for which of those purposes it is to be used;

(e)the name and address of the holder of any product licence which relates to such substance;

(f)where it is recommended that the substance should not be applied directly to the eye, a warning to that effect; and

(g)the name of any antimicrobial agent which is an ingredient of such substance and the percentage of that substance which that agent comprises, calculated in terms of weight in weight (w/w), weight in volume (w/v), or volume in volume (v/v) as appropriate.

(2) The particulars specified in paragraph (1)(f) shall be shown in capital letters and where the substance is or is to be sold or supplied in solid form as a powder or tablet those particulars shall be so expressed as to relate to the substance in the liquid form in which it is to be administered.

(3) In this regulation, the expression “contact lensrefers only to a contact lens which consists of a thin curved shell of glass, plastic or other hard or soft material intended for use by being applied to the human eyeball and the word “blankrefers only to a blank from which a contact lens is to be prepared.