BOTOX® 50U

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 Cosmetic can be injected directly into the muscles and can be used to control the following conditions:

• BOTOX cosmetic is used to reduce the symptoms of chronic migraine in adults who have had headaches on 15 or more days each month, of which at least 8 days are with migraine and who have not responded well to other preventative migraine medications.
• In adults, BOTOX cosmetic can be injected deep into the skin and can work on sweat glands to reduce excessive sweating of the armpits, which affects the activities of daily living when other local treatments do not help.
• BOTOX cosmetic is used for the temporary improvement in the appearance of:
• Vertical lines between the eyebrows seen at maximum frown
• Fan-shaped lines from the corner of the eyes seen at maximum smile
• Forehead lines seen at maximum raised eyebrows when the severity of the facial lines has an important psychological impact in adult patients.

BOTOX Cosmetic (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A intended for intramuscular use.

Each vial of BOTOX Cosmetic contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.

1. Contraindications

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

2. After-care

You or your caregiver should contact your doctor and seek medical attention immediately if you experience any of the following:

• Difficulty in breathing, swallowing, or speaking;
• Hives, swelling including swelling of the face or throat, wheezing, feeling faint and shortness of breath (possible symptoms of severe allergic reaction). Very rarely, an allergic reaction can occur after the injection of botulinum toxin.

Inform your doctor if you are being treated for facial lines and you see no significant improvement one month after your first course of treatment.