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BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity in adult patients aged 65 years or less. Important Safety Information BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection sites(s) and in individuals with known hypersensitivity to any ingredient in the formulation. Serious and/or immediate hypersensitivity reactions have been rarely reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further BOTOX® Cosmetic injection should be discontinued and appropriate medical therapy immediately instituted. BOTOX® Cosmetic should only be diluted with 0.9% nonpreserved sodium chloride. Other diluents, including lidocaine, should not be used for reconstitution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic. The most common side effects are headache, respiratory infection, flu syndrome, temporary eyelid droop, and nausea. BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation. Please see the additional safety information and full prescribing information. |
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