THERE’S ONLY ONE BOTOX ® COSMETIC.
Choose the brand medical providers and patients know and trust: BOTOX ® Cosmetic. It’s the #1 selling treatment of its kind*:
The first and only treatment FDA-approved to temporarily make moderate to severe frown lines, crow's feet and forehead lines look better in adults. A quick 10-minute treatment with minimal downtime You may begin to notice results within 24 to 48 hours for moderate to severe frown lines It delivers predictable, subtle results, so you look like you, only with less noticeable facial lines.
Ask for BOTOX® Cosmetic by name.
INDICATIONS AND USAGE
BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of (1):
• 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
DOSAGE AND ADMINISTRATION
• Botox Cosmetic is administered by intramuscular injection
• Glabellar Lines Administration: 0.1 mL (4 Units) into each of 5 sites, for a total dose of 20 Units (2.3)
• Lateral Canthal Lines Administration: 0.1 mL (4 Units) into each of 3 sites per side (6 total injection points), for a total of 24 Units (2.3)
• Forehead Lines Administration: 0.1 mL (4 Units) into each of 5 forehead line sites (20 Units) with 0.1 mL (4 Units) into each of 5 glabellar line sites (20 Units), for a recommended total of 40 Units (2.3)
• Follow dosage and administration recommendations. In treating adults for more than one approved indications with BOTOX and BOTOX Cosmetic, do not exceed a total dose of 400 Units administered in a 3 month interval
(2.1)
• See Preparation and Dilution Technique for instructions on BOTOX Cosmetic reconstitution, storage, and preparation before injection (2.2)
DOSAGE FORMS AND STRENGTHS
For Injection: 50 Units or 100 Units vacuum-dried powder in a single-use vial for reconstitution
CONTRAINDICATIONS
• Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation (4.1, 5.4)
• Infection at the injection site (4.2)
WARNINGS AND PRECAUTIONS
• Potency Units of BOTOX Cosmetic are not interchangeable with other preparations of botulinum toxin products
• Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur
• Potential serious adverse reactions after administration of BOTOX for unapproved uses
• Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease.
• Concomitant neuromuscular disorder may exacerbate clinical effects of treatment
• Use with caution in patients with compromised respiratory function or dysphagia (5.7)
ADVERSE REACTIONS
The most common adverse reactions are (6.1):
• Glabellar Lines: eyelid ptosis (3%)
• Lateral Canthal Lines: eyelid edema (1%)
• Forehead Lines: headache (9%) and brow ptosis (2%)
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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
