Betadine Skin Cleanser.

Povidone Iodine USP 4.00% w/v.

Topical aqueous solution.

Acne vulgaris of the face and neck. For general disinfection of the skin (as a liquid soap).

Route of administration: Topical. Adults, the elderly and children over 2 years: Apply directly or with moistened sponge to the affected areas and work up a rich lather. Allow to remain on the skin for 3-5 minutes then rinse off thoroughly with warm water and dry with a clean or sterile towel or gauze. Repeat twice daily. Infants under 2 years: Limit use to 2-3 days.

Hypersensitivity to iodine. History of abnormal thyroid function or goitre.

Do not use on broken skin. Iodine is absorbed through burns and broken skin and, to a lesser extent, through intact skin. Restrict use in infants to 2-3 days.

None known.

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

None known.

If local irritation or sensitivity develops, then discontinue treatment.

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.

Betadine Skin Cleanser 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 exfoliative debris and infected lesions whilst the colour persists. Betadine Skin Cleanser kills bacteria, viruses, fungi, spores and protozoa.

The product is intended for topical application.

Not applicable.

Purified water; potassium iodate; NPPE ester; lauric diethanolamide; Natrosol HXR; Vah Floral Perfume No 2; sodium hydroxide.

None known.

36 months

Store at a temperature not exceeding 25^oC.

Polypropylene container with polypropylene lid containing 250ml.

None stated.

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

PL 21248/0015.

30^th March 2005.

May 2006.