DERBAC M Cutaneous emulsion Ref.[49891] Active ingredients: Malathion

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, Ireland

Product name and form

Derbac M Liquid 0.5% w/w Cutaneous emulsion.

Pharmaceutical Form

Cutaneous Emulsion.

Creamy white perfumed emulsion.

Qualitative and quantitative composition

The liquid contains 0.5% w/w Malathion.

Also contains methyl parahydroxybenzoate (E218) 0.20% w/w and propyl parahydroxybenzoate (E216) 0.08% w/w.

For full list of excipients, see section 6.1.

Active Ingredient Description
Malathion
List of Excipients

Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Emulsifying wax
Potassium citrate
Citric acid
Perfume HT 52
Purified water

Pack sizes and marketing

Cartoned, clear or amber glass (Ph. Eur. Type III) bottles with polyethylene caps with an HDPE body, HDPE ring and a polyethylene LDPE plug containing either 50, 55, 150, 160, 200 or 210 ml of product. Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.

Marketing authorization holder

LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, Ireland

Marketing authorization dates and numbers

PA22702/001/001

Date of first authorisation: 13 July 1993
Date of last renewal: 13 July 2008

Drugs

Drug Countries
DERBAC-M Ireland, United Kingdom

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