BETAISODONA Cream Ref.[49797] Active ingredients: Povidone iodine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MUNDIPHARMA PHARMACEUTICALS LTD., 13, Othellos str., Dhali Industrial Zone, P.O. Box 23661, 1685 Nicosia, Cyprus Tel: +357 22815656 Fax: +357 22487833 e-mail: info@mundipharma.com.cy

Product name and form

Trademark: BETAISODONA 5,0%w/w Cream.

Generic (INN) Name: Povidone-Iodine.

Pharmaceutical Form

Cream.

For topical administration.

Qualitative and quantitative composition

Povidone-Iodine Ph. Eur. 5.0% w/w.

For the full list of 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

Cetostearyl alcohol
White soft paraffin
Sodium hydroxide
Liquid paraffin
Glycerol
Sorbitan stearate
Macrogol stearate
Polysorbate 60
Potassium iodate
Purified water

Pack sizes and marketing

Supplied in lacquered aluminium tubes, containing 5g, 15g or 40g of the product.

The tubes are enclosed in printed cartons.

Marketing authorization holder

MUNDIPHARMA PHARMACEUTICALS LTD., 13, Othellos str., Dhali Industrial Zone, P.O. Box 23661, 1685 Nicosia, Cyprus
Tel: +357 22815656
Fax: +357 22487833
e-mail: info@mundipharma.com.cy

Marketing authorization dates and numbers

14789

Date of first authorisation: 29 June 1994
Date of latest renewal: 22nd December 2014

Drugs

Drug Countries
BETAISODONA Austria, Cyprus, Germany
 
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