Betadine Skin Cleanser (Molnlycke Health Care )

1. Name Of The Medicinal Product

Betadine Skin Cleanser.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 4.00% w/v.

3. Pharmaceutical Form

Topical aqueous solution.

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

If local irritation or sensitivity develops, then discontinue treatment.

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

The product is intended for topical application.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

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

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store at a temperature not exceeding 25^oC.

6.5 Nature And Contents Of Container

Polypropylene container with polypropylene lid containing 250ml.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

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

8. Marketing Authorisation Number(S)

PL 21248/0015.

9. Date Of First Authorisation/Renewal Of The Authorisation

30^th March 2005.

10. Date Of Revision Of The Text

May 2006.