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

4.1. Therapeutic indications

For the topical treatment of rheumatic and muscular pain, sprains, strains, backache and neuralgia. Ibugel is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.

4.2. Posology and method of administration

Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. Do not use excessively.

Hands should be washed immediately after use (unless treating them).

Treatment should not normally continue for more than a few weeks, unless recommended to do so by a doctor.

The same dosage and dosage schedule applies to all age groups, although Ibugel is not normally recommended for use on children under the age of 12 years, unless instructed by their doctor.

4.9. Overdose

Not applicable. Any overdose with a topical presentation of ibuprofen is extremely unlikely.

6.3. Shelf life

30 g, 50 g and 100 g containers: 36 months from the date of manufacture.

4 g containers: 18 months from the date of manufacture.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

Not applicable.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.