BOTOX® (onabotulinumtoxinA) Important Information. Please scroll for BOTOX® Important Safety Information including Boxed Warning, full Prescribing Information and Medication Guide.
IMPORTANT SAFETY INFORMATION and PRESCRIBING INFORMATION FOR
BOTOX® Cosmetic (onabotulinumtoxinA) , JUVÉDERM® Injectable Gel Fillers, KYBELLA® (deoxycholic acid) injection 10 mg/mL , CoolSculpting® Treatment, CoolTone® Treatment, Natrelle® Breast Implants including Boxed Warning, REVOLVE™ ADVANCED ADIPOSE SYSTEM, SkinMedica®, LATISSE® (bimatoprost ophthalmic solution) 0.03%
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, 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, and 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, and/or forehead lines.
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 receive 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; have 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 over-the-counter medicines, vitamins, and herbal supplements. 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.
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 (tell your doctor 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: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
JUVÉDERM® Injectable Gel FillersImportant Information
JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
What warnings should my doctor advise me about?
- One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, 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 of the skin
- The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
What precautions should my doctor advise me about?
- JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbol
- The safety of these products for use during pregnancy or while breastfeeding has not been studied
- The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
- The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
- If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
- If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
- Tell your doctor if you are on therapy used to reduce your body’s natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site
- Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
- JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
- The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
- Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
What are possible side effects of treatment?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.
These side effects are consistent with other facial injection procedures and most will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information
What is KYBELLA®?KYBELLA® is a prescription medicine used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called “double chin.”
It is not known if KYBELLA® is safe and effective for the treatment of fat outside of the submental area or in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
Who should not receive KYBELLA®?
Do not receive KYBELLA® if you have an infection in the treatment area.
Before receiving KYBELLA®, tell your healthcare provider about all of your medical conditions, including if you have had or plan to have surgery on your face, neck, or chin; have had cosmetic treatments on your face, neck, or chin; have had or have medical conditions in or near the neck area; have had or have trouble swallowing; have bleeding problems; are pregnant or plan to become pregnant (it is not known if KYBELLA® will harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if KYBELLA® passes into your breast milk).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that prevents the clotting of your blood (antiplatelet or anticoagulant medicine).
What are the possible side effects of KYBELLA®?
KYBELLA® can cause serious side effects, including:
- Nerve injury in the jaw (which can cause an uneven smile or facial muscle weakness)
- Trouble swallowing
- Injection site problems, including a collection of blood under the skin (hematoma) or bruising, damage to an artery or vein if KYBELLA® is inadvertently injected into it, hair loss, open sores (ulcers), damage and tissue cell-death (necrosis) around the injection site, infection. Call your healthcare provider if you begin to develop weakness in the muscles of your face or your smile becomes uneven; have difficulty swallowing, or if any of the symptoms that you already have get worse; develop redness, pain, open sores, or drainage at or from the treatment area
The most common side effects of KYBELLA® include swelling, pain, numbness, redness, and areas of hardness in the treatment area.
These are not all of the possible side effects of KYBELLA®. Call your doctor for medical advice about side effects.
Please see KYBELLA® full Prescribing Information.
CoolSculpting® Treatment Important Information
CoolSculpting® is FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® is not a treatment for weight loss.
Important Safety Information
This procedure is not for everyone. You should not be treated with CoolSculpting® if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations lessen as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.
Rare side effects may happen in 1 to 10 out of 10,000 CoolSculpting® treatments (between 0.01% to 0.1%). One such rare side effect is a visible enlargement in the treated area which may develop two to five months after treatment, will not resolve on its own, and may require surgical intervention for correction.
Please see full Important Safety Information for CoolSculpting® on CoolSculpting.com
CoolTone® Uses and Important Safety Information
The CoolTone® device is FDA-cleared for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone® is also FDA-cleared for strengthening, toning, and firming of buttocks and thighs.
Important Safety Information
The CoolTone® procedure is not for everyone. You should not have the CoolTone® treatment in areas with metal, electrical, or electronic implants/devices like cardiac pacemakers, implanted hearing devices, implanted defibrillators, implanted neurostimulators, drug pumps, or hearing aids.
Tell your doctor if you have any medical conditions as CoolTone® should not be used over a menstruating uterus, over areas of the skin that lack normal sensation, in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy.
CoolTone® should be used with caution in patients with Graves’ disease (an autoimmune disorder that causes overactive thyroid), active bleeding disorders, or seizure disorders.
Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone® treatments, therefore, it is recommended to not undergo treatment during this time of the month.
CoolTone® should not be used in the heart or head areas, areas of new bone growth, over the carotid sinus nerves, or over the neck or mouth. CoolTone® should not be applied over swollen, infected, inflamed areas or skin eruptions. Caution should be used for patients with suspected or diagnosed heart problems.
Common side effects may include, but may not be limited to, muscular pain, temporary muscle spasm, temporary joint or tendon pain, and redness at or near the treatment site.
Ask your Healthcare Provider if CoolTone® is right for you.
Please see full Important Safety Information for additional information at coolsculpting.com/cooltone.
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
Who can get breast implants?
Natrelle® Breast Implants are approved for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants and for women at least 18 years old for saline-filled implants. Breast augmentation includes primary breast augmentation to increase the breast size and revision surgery to correct or improve the result of a primary breast augmentation
- Breast reconstruction. This includes primary breast reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. This also includes revision surgery to correct or improve the result of a primary breast reconstruction
Who should NOT get breast implants?
Breast implant surgery should NOT be performed in:
- Women with active infection anywhere in their body
- Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions
- Women who are currently pregnant or nursing
What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
- Autoimmune diseases (eg, lupus and scleroderma)
- A weakened immune system (eg, taking medications to decrease the body’s immune response)
- Planned chemotherapy or radiation therapy following breast implant placement
- Conditions or medications 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
- Those 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 else should I consider?
- There is a Boxed Warning for breast implants. Please see bold text at beginning
- Many changes to your breasts following implantation are irreversible. If you later choose to have your implants removed and not replaced, you may experience dimpling, puckering, wrinkling, or other cosmetic changes, which may be permanent
- Breast implantation is likely not a one-time surgery. The longer implants are in place, the greater the potential risk for complications. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. Thus, you should also consider the complication rates for later (revision) surgery since you may experience these risks in the future
- Cancer treatments and surgery will affect the outcome and timing of breast reconstruction
- 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. Even if you have no symptoms, you should have your first ultrasound or MRI at 5 to 6 years after your initial implant surgery and then every 2 to 3 years thereafter regardless of whether your implants are for augmentation or reconstruction. If you have symptoms of or uncertain ultrasound results for breast implant rupture, an MRI is recommended. Additional imaging may be required depending on your medical history and status. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established
- Routine screening mammography for breast cancer will be more difficult, and implants may rupture during the procedure. Perform self-examination every month for cancer screening and ask your surgeon to help you distinguish the implant from your breast tissue. Lumps, persistent pain, swelling, hardening, or changes in implant shape should be reported to your surgeon and possibly evaluated with imaging
What are key complications with breast implants?
Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility.
Talk to your doctor about other complications.
For more information, see the patient brochures at www.allergan.com/products.
To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of Natrelle® Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery.
REVOLVE™ and REVOLVE ENVI™ 600 ADVANCED ADIPOSE SYSTEM
CONSUMER INDICATIONS AND IMPORTANT SAFETY INFORMATION
How is REVOLVE™ System or REVOLVE ENVI™ 600 System used?
The REVOLVE™ Advanced Adipose System (REVOLVE™ System) and REVOLVE ENVI™ 600 Advanced Adipose System (REVOLVE ENVI™ 600 System) are used for aspiration, harvesting, filtering, and transferring of fat for aesthetic body shaping. The REVOLVE™ System and REVOLVE ENVI™ 600 System are intended for use in the following surgeries when drawing fat is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, bone or muscle surgery, gynecological surgery, thoracic surgery, and minimally invasive surgery.
IMPORTANT SAFETY INFORMATION
When should REVOLVE™ System or REVOLVE ENVI™ 600 System NOT be used?
The device should not be used by your physician if you currently have any disease that adversely affects wound healing, and poor overall health status.
What should I discuss with my doctor before my procedure?
The device will not, in and of itself, produce significant weight reduction. The device should be used by your physician with extreme caution if you have a chronic medical condition such as diabetes, heart, lung, or circulatory system disease, or obesity.
What else should I know?
The device is designed to remove localized deposits of excess fat through a small incision and subsequently transfer the tissue back to you. Use of the device is limited to those physicians who have the appropriate level of medical education and surgical experience in the appropriate surgical procedures. Results of the procedure will vary depending upon your age, surgical site, and experience of your physician. Results of the procedure may or may not be permanent.
What are possible side effects of the procedure?
Some common adverse effects associated with use of the REVOLVE™ System or REVOLVE ENVI™ 600 System and/or autologous fat transfer procedures are unevenness, over- and/or under-correction, tissue lumps, bleeding, scarring, fat cell death, formation of cysts, chronic immune system response, allergic reaction, infection and inflammation of various levels.
This information is not intended to replace a discussion with your surgeon and does not describe all the potential risks associated with fat transfer procedures. Please consult with your surgeon to determine if the use of REVOLVE™ System is right for you.
REVOLVE™ System and REVOLVE ENVI™ 600 System are for use only by a licensed physician.
For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVE™ System available at www.allergan.com/RevolveIFU and Instructions for Use (IFU) for REVOLVE ENVI™ 600 System at www.allergan.com/RevolveENVI-IFU or call 1.800.678.1605.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
Most of the SkinMedica® products described on this website 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 on these pages have not been evaluated by the FDA.
SkinMedica® Total Defense + Repair Broad Spectrum Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+) and Essential Defense Broad Spectrum Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35) 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® Purifying Foaming Wash is an over-the-counter drug product that are formulated and marketed pursuant to the FDA’s governing regulations set forth at 21 CFR Part 333 Subpart D.
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
Do not use LATISSE® if you are allergic to one of its ingredients. 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 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 gradually return to previous appearance.
These are not all the possible side effects of LATISSE®. For more information, please talk to your doctor.
Please see LATISSE® full Prescribing Information.
The DiamondGlow® device is a general dermabrasion device that gently removes the top layer of skin and delivers topical cosmetic serums onto the skin.
Important Safety Information
The DiamondGlow® treatment is not for everyone. You should not have a DiamondGlow® treatment if you have compromised skin quality. Tell your provider if you are pregnant or lactating, or if you have any medical conditions, including allergies, and if you are using topical medications on the area to be treated.
Typical side effects include a scratchy, stinging sensation during the treatment and temporary tightness, redness or slight swelling after the treatment. Rare serious side effects may also occur and include severe skin irritation and allergic reactions.
SkinMedica® Pro-Infusion Serums Disclaimer
SkinMedica® Pro-Infusion Serums 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 products are not intended to be drugs 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.
Claims for Ocumend® are based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Please talk to your provider for additional information.