IBUGEL Gel Ref.[50003] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire SG4 7QR, UK

Product name and form

Ibugel.

Pharmaceutical Form

Gel.

Non-greasy, fragrance-free, clear aqueous-alcoholic gel.

Qualitative and quantitative composition

Ibuprofen 5.0% w/w.

Excipients with known effect: 1g of cream contains 20 mg of propylene glycol (E1520).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

IMS
Carbomer
Propylene glycol (E1520)
Diethylamine
Purified Water

Pack sizes and marketing

1) Membrane sealed, epoxy resin coated, collapsible aluminium tube, fitted with a screw cap (containing 4 g, 30 g, 50 g or 100 g of product)

2) Membrane-sealed laminate tube, made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with a screw cap (containing 30 g, 50 g or 100 g of product)

3) Laminate tube made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with an air-return-free ‘Precitube’ pump head and cap (containing 30 g, 50 g or 100 g of product).

Not all pack sizes may be marketed.

Marketing authorization holder

Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire SG4 7QR, UK

Marketing authorization dates and numbers

PL 00173/0050

14 January 1991/2 September 2008 for 02 September 2007 renewal date, unlimited validity granted.

Drugs

Drug Countries
IBUGEL Ireland, United Kingdom

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