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Click here to see IMPORTANT SAFETY INFORMATION for BOTOX® Cosmetic (onabotulinumtoxinA),
JUVÉDERM® XC, JUVÉDERM VOLUMA® XC, KYBELLA®
(deoxycholic acid) injection 10 mg/mL, Natrelle® Breast Implants, and LATISSE®
(bimatoprost ophthalmic solution) 0.03% below.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crow’s feet lines and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, or both at the same time.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc®(rimabotulinumtoxinB), Dysport®(abobotulinumtoxinA), or Xeomin®(incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles: trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of your eyelids.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® is an FDA-approved treatment to grow eyelashes for people with inadequate or not enough lashes.
Important Safety Information
If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. May cause brown darkening of the colored part of the eye which is likely permanent. LATISSE® may cause eyelid skin darkening which may be reversible. Only apply at base of the upper lashes. DO NOT APPLY to lower lid. Hair may grow outside the treatment area. If you have eye problems/surgery, consult your doctor. Common side effects include itchy and red eyes. If discontinued, lashes will gradually return to previous appearance.
To report a side effect, please call Allergan at 1-800-433-8871.
KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information
KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
IMPORTANT SAFETY INFORMATION
KYBELLA® should only be administered by a trained healthcare professional.
KYBELLA® is contraindicated in the presence of infection at the injection sites.
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range 1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition.
In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
JUVÉDERM® XC, JUVÉDERM® Ultra XC and
JUVÉDERM VOLUMA® XC Important Information
JUVÉDERM® XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
JUVÉDERM® Ultra XC is for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM VOLUMA® XC injectible gel is for deep injection in the cheek area to correct age-related volume loss in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any
JUVÉDERM® injectable gel formulation?
Do not use these products if you have a history of multiple severe allergies or severe
allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the gram-positive
bacterial proteins used in these products.
What precautions should my doctor advise me about?
Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years,
and the safety of JUVÉDERM VOLUMA® XC for patients under 35 years or over 65 years
has not been studied
The safety and effectiveness of JUVÉDERM® XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC for areas other than the lips and perioral area for lip augmentation, or facial wrinkles and folds, have not been established in clinical studies
The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area have not been established in clinical studies
Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
Patients who experience skin injury near the site of injection with these products
may be at a higher risk for side effects.
Tell your doctor if you are on immunosuppressive therapy used to decrease the body's
immune response, as use of these products may result in an
increased risk of infection.
Tell your doctor if you are using medications that can prolong
bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in
increased bruising or bleeding at the injection site.
Minimize strenuous exercise and exposure to extensive sun or heat, and alcoholic beverages within the first
24 hours following treatment
What are possible side effects?
The most common side effects include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. With JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels, most side effects are mild or moderate and last 14 days or less. For JUVÉDERM VOLUMA® XC side effects are moderate (uncomfortable) and last 2 to 4 weeks
One of the risks with using this product is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.
As with all skin-injection procedures, there is a risk of infection.
To report a side effect with JUVÉDERM® XC, JUVÉDERM® Ultra XC or JUVÉDERM
VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-
4261. For more information, please see www.juvederm.com or call-Allergan
Medical Information at 1-800-433-8871.
Available by prescription only.
Natrelle®Breast Implants Important Information
WHO MAY GET BREAST IMPLANTS (INDICATIONS)? Natrelle®Breast Implants are indicated for women for the following :
Breast augmentation for women at least 22 years old for silicone-filled implants.
Breast augmentation for women at least 18 years old for saline-filled implants.
Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
IMPORTANT SAFETY INFORMATION Who should NOT get breast implants (CONTRAINDICATIONS)?
Women with active infection anywhere in their body.
Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
Women who are currently pregnant or nursing.
What else should I consider (WARNINGS)?
Breast implants are not lifetime devices, and not necessarily a one-time surgery.
Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent.
Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain tingling, swelling, numbness, burning or hardening. Tell your doctor of these symptoms and remove ruptured implants.
Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the implants.
What types of conditions require more study (PRECAUTIONS)?
Caution: Notify your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
Autoimmune diseases (for example, lupus and scleroderma).
A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease).
Planned chemotherapy following breast implant placement.
Planned radiation therapy to the breast following breast implant placement.
Conditions that interfere with wound healing and blood clotting.
Reduced blood supply to breast tissue.
Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients with a diagnosis of depression or other mental health disorders should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery.
What are some complications with breast implants (COMPLICATIONS)?
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling. Talk to your doctor about other complications.
Talk to your doctor. For more information see the Patient Brochures at www.allergan.com/labeling/usa.htm or call the Allergan Product
Support line at 1-800-433-8871.
To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.
Natrelle® Breast Implants are available by prescription only.
Most of the SkinMedica® products described here are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA.
SkinMedica® Total Defense + Repair Broad Spectrum Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+), Essential Defense Broad Spectrum Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35), Daily Physical Defense® Sunscreen Broad Spectrum SPF 30+, Environmental Defense Sunscreen™ SPF 50+ with UV ProPlex™, and TNS Ultimate Daily Moisturizer™ SPF 20 Sunscreen are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. Part 352.
SkinMedica® Acne System, Acne Treatment Lotion, Purifying Foaming Wash, and Purifying Toner, are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. § 333.301 et seq.