Apply with gentle massage only.
Discontinue if rash develops.
Hands should be washed immediately after use.
Not for use with occlusive dressings.
Keep away from the eyes and mucous membranes.
Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients.
Although systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, patients with an active peptic ulcer, a history of kidney problems, asthma or intolerance to aspirin or ibuprofen taken orally should seek medical advice before using the gel as should patients already taking other painkillers.
The label should include the following warnings:
• Do not apply more of this medicine than the label tells you to.
• Not recommended for children under 12 years.
• Use this medicine only on your skin.
• Not to be used during pregnancy or breastfeeding.
• Do not use if you are allergic to any of the ingredients or have experienced problems with aspirin, ibuprofen or related painkillers (including when taken by mouth).
• If symptoms do not get better after 2 weeks or if they worsen, consult your doctor or pharmacist.
• Keep out of the sight and reach of children.
• Patients with asthma, an active peptic ulcer or history of kidney problems should consult their doctor before use, as should patients already taking aspirin or other painkillers.
Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity.