BOTOX® is a botulinum type A product. A wrinkle injection that treats glabellar lines and other wrinkles by temporarily blocking the release of acetylcholine from nerves, helping prevent muscle movement in the area and relaxing the skin.

BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of:

• Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
• Moderate to severe lateral canthal lines associated with orbicularis oculi activity
• Moderate to severe forehead lines associated with frontalis muscle activity

BOTOX is a muscle relaxant used to treat a number of conditions within the body. It contains the active substance botulinum toxin type A and is injected into either the muscles, the bladder wall, or deep into the skin. It works by partially blocking the nerve impulses to any muscles that have been injected and reduces excessive contractions of these muscles. When injected into the skin, BOTOX works on sweat glands to reduce the amount of sweat produced, or to give a temporary improvement in the appearance of vertical lines between the eyebrows seen at maximum frown (glabellar lines) or fan-shaped lines from the corner of the eyes seen at maximum smile (crow’s feet lines) or forehead lines seen at maximum raised eyebrows. When injected into the bladder wall, BOTOX works on the bladder muscle to reduce leakage of urine (urinary incontinence). In the case of chronic migraine, it is thought that BOTOX may block pain signals which indirectly block the development of a migraine. However, the way BOTOX works in chronic migraine is not fully established.

• The potency Units of BOTOX Cosmetic (onabotulinumtoxinA) for injection are specific to the preparation and assay method utilized. 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.
• Indication specific dosage and administration recommendations should be followed.
• In treating adult patients for one or more indications with BOTOX and BOTOX Cosmetic, the maximum cumulative dose should generally not exceed 400 Units, in a 3 month interval.
• The safety and effectiveness of dosing with BOTOX Cosmetic more frequently than every 3 months have not been clinically evaluated.
• The safe and effective use of BOTOX Cosmetic depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. Physicians administering BOTOX Cosmetic must understand the relevant neuromuscular and structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease.

Contraindications

• Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
• Infection at the injection site

After-care

Patients receiving concomitant treatment of BOTOX Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of BOTOX Cosmetic may be potentiated.