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Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.Cosmetic are specific to the preparation and assay method utilized.Hypersensitivity Reactions Serious and/or immediate hypersensitivity reactions have been reported.These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea.
Swallowing and breathing difficulties can be life threatening and there have been reports of death.
In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Human Albumin and Transmission of Viral Diseases This product contains albumin, a derivative of human blood.
Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.
These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties.
They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.