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Safety Data Sheets

Belotero:

Belotero Balance® Safety Data Sheet

Neocutis:

Bio Cream Firm Smoothing & Tightening Cream Safety Data Sheet
Bio Cream Firm Riche Extra Moisturizing Smoothing & Tightening Cream Safety Data Sheet
BIO•GEL Firm Moisturizing Hydrogel Safety Data Sheet
BIO SERUM FIRM Safety Data Sheet
HYALIS+ Safety Data Sheet
LUMIÈRE® FIRM Safety Data Sheet
LUMIÈRE® FIRM RICHE Safety Data Sheet
NEO•CLEANSE® – Exfoliating Skin Cleanser Safety Data Sheet
NEO•CLEANSE® – Gentle Skin Cleanser Safety Data Sheet
PERLE® – Skin Brightening Cream Safety Data Sheet

Radiesse:
RADIESSE® Injectable Implant Safety Data Sheet
RADIESSE® (+) Lidocaine Injectable Implant Safety Data Sheet

Xeomin:
Xeomin® / NT201 Safety Data Sheet

Ultherapy:
Ulthera® System Safety Data Sheet

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The ULTHERA® System is indicated to lift skin on the neck, the eyebrows, and under the chin, as well as to improve lines and wrinkles on the décolleté, and to improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms. Reported adverse events from post-marketing surveillance are available in the Instructions for Use (IFU).

The BELOTERO® range of Hyaluronic Acid fillers are injectable resorbable implants indicated to increase the volume of skin tissue for the correction of facial depressions or remodeling the contours of the face. Consult the Instructions for Use for important information about:

  • Serious warnings and precautions regarding risk of embolization, occlusion of the vessels, ischemia, or infarction, temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, skin necrosis, and damage to underlying facial structures
  • Adverse reactions such as redness, erythema, oedema, pain, hematomas, swelling, indurations, nodules, coloration or discoloration, allergic reaction, abscesses and granulomas

    • A complete list of warnings, precautions, and other important safety information can be found in the Instructions for Use. You can request the Instructions for Use for any BELOTERO® injectable filler product by calling us at 1-866-815-8715.

    RADIESSE® and RADIESSE® (+) are indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and for the rejuvenation of the hand. RADIESSE® injectable implant diluted 1:2 with 0.9% sterile saline for injections is intended for the treatment of moderate and severe décolleté wrinkles.

    Warnings:

  • As with all dermal fillers, introduction of RADIESSE® or RADIESSE® (+) injectable implant into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
  • Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.
  • Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure.
  • Patients should receive prompt medical attention and possibly evaluation by an appropriate healthcare practitioner specialist should an intravascular injection occur.
  • Use of RADIESSE® or RADIESSE® (+) injectable implant in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
  • Injection procedure reactions have been observed consisting mainly of short-term (i.e., <7 days) bruising, redness, swelling, lumpiness, pain, itching, discolouration, and tenderness.
  • Do not overcorrect (overfill) a contour deficiency because the depression should gradually improve within several weeks as the treatment effect of RADIESSE® (+) injectable implant occurs. In extreme cases site rupture could occur with overcorrection.
  • Not intended for use in the breasts or for use in the lips.

    • Consult the Instructions for Use for a complete list of warnings, precautions, and other important safety information. The Instructions for Use are available by calling us at 1-866-815-8715 or found here.

    INDICATION AND CLINICAL USE:

    XEOMIN COSMETIC® (incobotulinumtoxinA) is indicated in adults for:

    • The temporary improvement in the appearance of moderate to severe horizontal forehead lines, lateral canthal lines, and glabellar lines

    SERIOUS WARNINGS AND PRECAUTIONS:

  • The term "unit" or "U" upon which dosing is based, is a specific measurement of toxin activity that is unique to XEOMIN COSMETIC®. Therefore, the "unit" or "U" used to describe XEOMIN COSMETIC® activity are different from those used to describe that of other botulinum toxin preparations and the units representing XEOMIN COSMETIC® activity are not interchangeable with other products.
  • XEOMIN COSMETIC® should only be given by physicians with the appropriate qualifications and experience in the treatment and the use of required equipment.
  • Follow the recommended dosage and frequency of administration for XEOMIN COSMETIC®, see DOSAGE AND ADMINISTRATION IN THE PRODUCT MONOGRAPH.
  • DISTANT SPREAD OF TOXIN EFFECT: The effects of XEOMIN COSMETIC® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

    • CONTRAINDICATIONS:

    • Infection or inflammation at proposed injection site(s)
    • Generalized disorders of muscle activity

    OTHER RELEVANT WARNINGS AND PRECAUTIONS:

    • Use XEOMIN COSMETIC® only as directed.
    • For safe and effective use, ensure proper storage, dosage, reconstitution, and administration.
    • Prior to injection, assess patient anatomy and any alterations to the anatomy.
    • Do not inject into a blood vessel. Failure to target desired musculature may result in apparent lack of efficacy.
    • If injection sites are marked with pen, do not inject through the pen marks or a permanent tattooing effect may occur.
    • Injections should generally be no more frequent than every three months, although injection intervals need to be tailored to patient's needs. Follow indication-specific dosage and administration recommendations.
    • Use caution for patients with bleeding disorders and in patients receiving anticoagulant therapy or other anticoagulant substances.
    • Hypersensitivity reactions have been reported with botulinum neurotoxin products. Neutralizing antibodies to botulinum toxins have been reported, and especially related to high dosage, too frequent injections, and higher total dosage. Antibody development may lead to treatment failure.
    • Symptoms of local spread of toxin effects (e.g., eyelid ptosis, facial paresis) were reported in clinical studies. Combined treatment of multiple areas may increase the risk of spread to distal areas, such as the oral pharyngolaryngeal region. Advise patients to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
    • To reduce complications of blepharoptosis, avoid injection near the levator palpebrae superioris and the cranial portions of the orbicularis oculi, particularly in patients with larger brow depressor complexes. Place medial corrugator injections in the central portion of the muscle belly at least 1 cm above the bony supraorbital ridge.
    • XEOMIN COSMETIC® is not recommended for patients with a history of dysphagia and aspiration.
    • Use caution in patients suffering from amyotrophic lateral sclerosis (ALS) or other diseases which result in peripheral neuromuscular dysfunction, and in muscles with pronounced weakness or atrophy.
    • XEOMIN COSMETIC® should not be used during pregnancy. The use of XEOMIN COSMETIC® during lactation is not recommended.
    • Counsel patients that if asthenia, muscle weakness, vision disorders, dizziness, or drooping eyelids occur they should avoid hazardous activities such as driving and using machines.
    • The safety and efficacy of XEOMIN COSMETIC® have not been established in pregnant patients. The use of XEOMIN COSMETIC® during lactation is not recommended.

    FOR MORE INFORMATION: Consult the Product Monograph at this link for information regarding adverse reactions, interactions, and dosing. The Product Monograph is also available by calling the product safety department at 1-866-815-8715.