Betadine Dry Powder Spray.

Povidone Iodine 2.5% w/w.

Pressurised aerosol spray.

Antiseptic for the treatment and prevention of infection in wounds including ulcers, burns, cuts and other minor injuries.

For topical use only. Adults and children aged 2 years and over: Shake the can well before use. Spray the required area from a distance of 15-25cm (6-10 inches) until a dusting of powder is deposited. If necessary, the treated area may be covered with a dressing.

Hypersensitivity to iodine. Betadine Dry Powder Spray should not be used in serous cavities. Do not use this product regularly if the patient suffers from thyroid disorders or is receiving concurrent lithium therapy. Do not use on children under two years of age.

Avoid inhaling or spraying into the eyes. Avoid use on patients with renal impairment. Should evidence of local irritation or sensitivity occur, use of the product should cease. If no improvement occurs, a doctor should be consulted.

Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects.

Use in pregnancy or lactation should be limited. Although no adverse effects are anticipated from such limited usage, caution is recommended and therapeutic benefit must be balanced against the possible effects of the absorption of iodine on foetal thyroid function and development.

None known.

Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin. Following prolonged application of Betadine Dry Powder Spray to severe burns or large areas of denuded skin, systemic effects such as metabolic acidosis, parametrical renal impairment and thyroid dysfunction may occur.

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.

Treatment: In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

Povidone iodine is a complex of iodine which retains the broad-spectrum germicidal activity of the elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.

Not applicable.

None stated.

Isopropyl myristate; n-pentane; butane 40; soya lecithin.

None known.

36 months unopened.

Store at or below 25^oC.

Aerosol cans containing 100ml of product.

None.

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

PL 21248/0005.

19^th April 2006.

April 2006.