IBULEVE Gel Ref.[50235] 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

Ibuleve Gel / Ibuleve Sports Gel.

Pharmaceutical Form

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

Qualitative and quantitative composition

Ibuprofen 5.0% w/w.

Excipient with known effect: 1 g of gel 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, 40 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 CAP (containing 30 g, 40 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, 40 g, 50 g or 100 g of product).

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00173/0413

01/08/2019

Drugs

Drug Countries
IBULEVE Israel, United Kingdom, South Africa
 
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