CARBOSAN Gel Ref.[9184] Active ingredients: Carbenoxolone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

Product name and form

Carbosan 2% w/w Gel.

Pharmaceutical Form


A translucent, colourless gel with a lemon odour.

Qualitative and quantitative composition

Each 5 g of Carbosan Gel contains 100 mg carbenoxolone sodium.

Excipient(s) with known effect:

0.60% w/w parahydroxybenzoic acid esters, sodium salt
0.10% w/w lemon oil containing limonene in a range of 0.056 % w/w – 0.078% w/w
16.50% w/w polyoxyethylene 30 cetylstearyl alcohol

For the full list of excipients, see section 6.1

Active Ingredient Description

Carbenoxolone is a glycyrrhetinic acid derivative with a steroid-like structure, similar to substances found in the flavor-ful root of the licorice plant. It influences endogenous glucocorticoids by potently inhibiting 11β-hydroxysteroid dehydrogenase. Electrolyte imbalance is a serious side effect of carbenoxolone when used systemically. Carbenoxolone is best known in cellular physiology as a modestly potent, reasonably effective, water-soluble blocker of gap junctions. It exerts anti-inflammatory activity. Carbenoxolone has used orally in the clinical treatment of peptic ulcers, now it is used topically for the treatment of lip sores and mouth ulcers.

List of Excipients

Polyoxyethylene-30-cetylstearyl alcohol
Polyol fatty acid ester
Iso-Octyl stearate
Imidazolidinyl urea
Sodium methylparahydroxybenzoic acid
Sodium ethylparahydroxybenzoic acid
Sodium propylparahydroxybenzoic acid
Lemon oil
Purified water

Pack sizes and marketing

The immediate container for Carbosan Gel is an aluminium tube that has an external white lacquer and a gold coloured internal lacquer coating. The tube has a white screw-on cap.

Pack size: 5g.

Marketing authorization holder

Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers


Date of first authorisation: 13 March 1987
Date of last renewal: 13 March 2007


Drug Countries
CARBOSAN Ireland, Malta

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