Betadine Shampoo.

Povidone Iodine 4.00% w/v.

Shampoo for cutaneous use.

Seborrhoeic conditions of the scalp associated with excessive dandruff, pruritis, scaling, exudation and erythema of the scalp, pityriasis capitis; infected lesions of the scalp - pyodermas (recurrent furunculosis, infective folliculitis and impetigo).

Route of administration: topical use. Adults and children over 12 years: Having first wetted the hair, apply 2 or 3 capfuls of Betadine Shampoo, use warm water to lather. Rinse. Again, apply 2 or 3 capfuls of Betadine Shampoo and massage into the scalp with the tips of the fingers. Work up to a golden lather using warm water. Repeat treatment twice weekly until improvement is noted. Afterwards, use Betadine Shampoo once a week. Children aged 2 to 12 years: As for children over 12 years, substituting 1 or 2 capfuls of Betadine Shampoo. Children under 2 years: Contraindicated.

Known or suspected iodine hypersensitivity. Regular use is contra-indicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis). Not for use in children under two years.

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.

Absorption of iodine from povidone iodine through either intact or broken skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.

None known.

Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine.

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. 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.

Betadine Shampoo contains povidone iodine, a complex of iodine which shows all the broad-spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. Povidone iodine kills bacteria, viruses, fungi, spores and protozoa.

The product is intended for topical application.

None stated.

Sulphated nonylphenoxypoly (oxyethylene) lauric diethanolamide; ethoxylated lanolin 50%; Natrosol HXR; perfume Vah Floral No 2; potassium iodate; sodium hydroxide; purified water.

None.

24 months unopened.

Store in a dry place at or below 25^oC and protected from light.

White polypropylene containers fitted with white polypropylene lids, containing 250ml of product.

None stated.

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

PL 21248/0013.

19^th July 2006.

July 2006.