BOTOX and Injectable Gel
BOTOX Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age.
Cosmetic Important Safety Information
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. There have been rare reports of adverse events involving the cardiovascular system. Serious and/or immediate hypersensitivity reactions have been reported rarely. These reactions include anaphylaxis, urticaria, soft-tissue edema, and dyspnea.
The most common adverse events following injection include blepharoptosis and nausea. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Patients with neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious adverse events.
JUVÉDERM Injectable Gel
A Brief Description of Relevant Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events
Indication: In the United States, JUVÉDERM injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Contraindications: JUVÉDERM injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies. JUVÉDERM injectable gel should not be used in patients with a history of allergies to Gram-positive bacterial proteins.
Warnings: JUVÉDERM injectable gel should not be injected into blood vessels. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.
Precautions: The safety of JUVÉDERM injectable gel for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established. The safety and effectiveness of JUVÉDERM injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies. Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at injection site. Patients should inform their physician before treatment if they are using these types of substances. As with all skin-injection procedures, there is a risk of infection. JUVÉDERM injectable gel should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body’s immune response, as there may be an increased risk of infection. The safety of JUVÉDERM injectable gel in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied. If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment with JUVÉDERM injectable gel, or if JUVÉDERM injectable gel is administered before the skin has healed completely after such a procedure, there is a possible risk of an inflammatory reaction at the treatment site.
Adverse events: The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, and bruising. Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less).
Important: For full safety information, please visit www.juvederm.com or call Allergan Product Support at 1-877-345-5372.
CAUTION: This device is restricted to sale by or on the order of a physician.