BETADINE Pressurised aerosol spray Ref.[7983] Active ingredients: Povidone iodine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, UK

Product name and form

Betadine Dry Powder Spray.

Pharmaceutical Form

Pressurised aerosol spray.

Qualitative and quantitative composition

Povidone iodine 2.5 %w/w.

For excipients, see section 6.1.

Active Ingredient Description
Povidone iodine

Povidone iodine is an iodophore that has an established use as a broad-spectrum antiseptic, mainly for the treatment of contaminated wounds and for the preoperative preparation of the skin, mucous membranes and the ocular surface. The organic complex contains approximately 10% of active available iodine. Solutions of povidone iodine gradually release iodine to exert an antimicrobial effect against bacteria, fungi, viruses, and spores. Although povidone iodine is less potent than preparations containing free iodine, it is also less toxic.

List of Excipients

Isopropyl myristate
N-pentane
Butane 40
Soya lecithin

Pack sizes and marketing

Aerosol cans, containing 50, 100 or 150ml of product.

Not all pack sizes may be marketed.

Marketing authorization holder

Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, UK

Marketing authorization dates and numbers

PL 16431/0190

19 April 2006

Drugs

Drug Countries
BETADINE Australia, Spain, Finland, France, Hong Kong, Croatia, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa

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