BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicate that is injected into muscles and used to temporarily improve the look of centrist to severe frontal bone 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 consort muscles, can be severe and result in loss of life. You are at the highest risk if these problems are preexistent 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 dispersed of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, brag ’ s feet lines, and/or brow lines .
BOTOX® Cosmetic may cause loss of lastingness or general muscle helplessness, 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 : rub, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feel faint. Get aesculapian help correctly 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 botulinus toxin product such as Myobloc® ( rimabotulinumtoxinB ), Dysport® ( abobotulinumtoxinA ), or Xeomin® ( incobotulinumtoxinA ) ; have a clamber infection at the planned injection locate .
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig ’ randomness disease, myasthenia gravis gravis, or Lambert-Eaton syndrome, as you may be at increase risk of good side effects including trouble immerse and difficulty breathe from distinctive doses of BOTOX® Cosmetic .
Tell your doctor about all your medical conditions, including : plans to have operation ; had surgery on your face ; have trouble raising your eyebrows ; drooping eyelids ; any other abnormal facial change ; are meaning or plan to become fraught ( 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 herb tea supplements. Using BOTOX® Cosmetic with certain other medicines may cause unplayful 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 botulinus toxin product in the last 4 months ; have received injections of botulinus toxin such as Myobloc®, Dysport®, or Xeomin® in the past ( tell your doctor precisely which product you received ) ; have recently received an antibiotic by injection ; take brawn relaxants ; take an allergy or cold medicine ; take a sleep medicine ; take aspirin-like products or rake thinners .
Other side effects of BOTOX® Cosmetic include : dry mouth ; discomfort or pain at the injection locate ; tiredness ; concern ; 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 consult 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 entire Product Information including Boxed Warning and Medication Guide .
JUVÉDERM® Injectable Gel Fillers Important Information
JUVÉDERM® VOLUMA® XC injectable mousse is for deeply injection in the cheek area to correct age-related bulk passing and for augmentation of the kuki region to improve the kuki 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 centrist 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 besides 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 sass 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 hard 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 acidic 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 unplayful and may be permanent. These complications, which have been reported for facial injections, can include sight abnormalities, blindness, stroke, temp scab, or permanent wave scar of the skin
- The use of cuticular 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 normally reported side effects with JUVÉDERM® injectable gels were red, swelling, annoyance, softheartedness, steadiness, lumps/bumps, hurt, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dispassion was besides reported.
These side effects are reproducible with other facial injection procedures and most will resolve with time. Your sophisticate 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 bark 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 license doctor or by rights licensed practitioner .
KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information
IMPORTANT SAFETY 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 ), besides called “ double chin. ”
It is not known if KYBELLA® is safe and effective for the treatment of fat outside of the submental sphere or in children under 18 years of age .
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 operation on your face, neck, or kuki ; 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 swallow ; have bleeding problems ; are meaning or design to become fraught ( it is not known if KYBELLA® will harm your unborn child ) ; are breastfeeding or plan to breastfeed ( it is not known if KYBELLA® passes into your front milk ) .
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. specially tell your healthcare supplier if you take a medicine that prevents the clog 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. 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 open sores or drainage from the treatment area
The most common side effects of KYBELLA® include swell, pain, apathy, inflammation, and areas of hardness in the treatment area.
These are not all of the possible side effects of KYBELLA®. Call your doctor for checkup advice about side effects .
Please see KYBELLA® wax Prescribing Information, or ask your healthcare supplier, or travel to MyKybella.com .
CoolSculpting® Treatment Important Information
CoolSculpting® is FDA-cleared for the treatment of visible fatness bulges in the submental ( under the chin ) and submandibular ( under the jawline ) areas, second joint, abdomen, and flank, along with brassiere fatty, back fat, underneath the buttocks ( besides known as banana roll ), and upper arm. It is besides FDA-cleared to affect the appearance of lax weave 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, coldness agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your repair if you have any aesculapian conditions including late surgery, preexistent hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, meek crimp, intense cold, tingling, stinging, aching, and cramping at the treatment locate. These sensations lessen as the area becomes numb. Following the routine, typical side effects include impermanent inflammation, swelling, pale, bruise, firmness, tingling, stinging, softheartedness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the binding 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 slope effect is a visible expansion in the tempered area which may develop two to five months after discussion, will not resolve on its own, and may require surgical intervention for discipline.
Please see broad Important Safety Information for CoolSculpting® on CoolSculpting.com
CoolTone® Treatment Important Information
The CoolTone® device is FDA-cleared for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone® is besides FDA-cleared for strengthening, toning, and tauten of buttocks and thighs .
Important Safety Information
The CoolTone® procedure is not for everyone. You should not have the CoolTone® treatment in areas with alloy, electrical, or electronic implants/devices like cardiac pacemakers, implanted listening devices, implant defibrillators, implant neurostimulators, drug pumps, or hearing aids .
Tell your repair if you have any medical conditions as CoolTone® should not be used over a menstruate uterus, over areas of the skin that lack normal sensation, in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical routine, pneumonic insufficiency, or pregnancy.
CoolTone® should be used with circumspection in patients with Graves ’ disease ( an autoimmune disorderliness that causes hyperactive thyroid ), active shed blood disorders, or capture disorders .
Women who are near to menstruation may find that it comes preferably, or hamper is increased or intensified with CoolTone® treatments, consequently, it is recommended to not undergo treatment during this time of the calendar month .
CoolTone® should not be used in the heart or head areas, areas of raw bone increase, over the carotid fistula nerves, or over the neck or mouth. CoolTone® should not be applied over conceited, infect, inflame areas or bark eruptions. caution should be used for patients with distrust or diagnose heart problems .
common side effects may include, but may not be limited to, brawny trouble, temp muscle spasm, irregular joint or tendon pain, and red at or near the treatment web site .
Ask your Healthcare Provider if CoolTone® is correct for you .
Please see full Important Safety Information for extra 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 watch :
- 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 operation 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 pursuit conditions, as the risks of breast implant operating room 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 refilling, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture ( hard scratch weave around the implant ). other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scar, 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 data to patients about the risks and benefits of breast implant operating room .
REVOLVE™ ADVANCED ADIPOSE SYSTEM
CONSUMER INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is the REVOLVE™ System?
The REVOLVE™ Advanced Adipose System ( REVOLVE™ System ) is used for aspiration, harvest, filter, and transplant of fatness for aesthetic body shaping. The REVOLVE™ System is intended for manipulation in the following surgeries when drawing fatness is desired : plastic and reconstructive operating room, gastrointestinal and affiliated organ operating room, urological surgery, general operation, bone or brawn surgery, gynecological operating room, pectoral operation, and minimally incursive operating room.
IMPORTANT SAFETY INFORMATION
Who should NOT use REVOLVE™ System?
REVOLVE™ System should not be used by your doctor if you presently have any disease that adversely affects wound curative, and poor overall health condition.
What warnings should I be aware of?
REVOLVE™ System will not, in and of itself, produce significant weight passing. This device should be used by your doctor with extreme caution if you have a chronic aesculapian condition such as diabetes, heart, lung, or circulative system disease, or fleshiness.
What precautions should I be aware of?
REVOLVE™ System is designed to remove localize deposits of excess fat through a small incision and subsequently transfer the tissue binding to you. Use of this device is limited to those physicians who have the appropriate tied of medical education and surgical experience in the appropriate surgical procedures. Results of the routine will vary depending upon your age, surgical locate, and experience of the doctor. Results of the routine may or may not be permanent.
What are possible side effects?
Some common adverse effects associated with fat transfer are unevenness, over- and/or under-correction, weave lumps, bleeding, and scarring. likely adverse effects associated with REVOLVE™ System include adipose tissue cellular telephone end, formation of cysts, infection, chronic immune organization answer, allergic reaction and inflammation.
REVOLVE™ System is available by prescription only.
This information is not intended to replace a discussion with your surgeon. It does not describe all the potential risks associated with fat grafting procedures. Every patient’s situation is different, so please consult with your surgeon to determine if the use of REVOLVE™ System is right for you.
For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVE™ System.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
Most of the SkinMedica® products described on this web site are intended to meet the FDA ’ s definition of a cosmetic product, an article applied to the homo body to cleanse, beautify, promote attraction, and change 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 nonprescription 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 nonprescription drug products which are formulated and marketed pursuant to FDA ’ s governing regulations set forth at 21 C.F.R. 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 manage. May cause brown blackening of the color partially of the eye which is likely permanent. LATISSE® may cause eyelid clamber darkening which may be reversible. only apply at base of upper lashes. DO NOT APPLY to lower hat. Hair may grow outside the discussion area. If you have eye problems/surgery, consult your repair. coarse side effects include itchy and red eyes. If discontinued, lashes gradually return to former 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® device is a cosmopolitan dermabrasion device that lightly removes the top layer of skin and delivers topical cosmetic serums onto the skin. The DiamondGlow® treatment is not for everyone. You should not have a DiamondGlow® treatment if you have compromised skin quality. Tell your supplier if you are fraught or wet, or if you have any checkup conditions, including allergies, and if you are using topical medications on the area to be treated .
distinctive side effects include a cranky, stinging sensation during the discussion and temp concentration, inflammation or rebuff swell after the treatment. Rare good side effects may besides occur and include severe clamber aggravation and allergic reactions .
Pro-Infusion Serums Disclaimer
The Pro-Infusion Serums are intended to meet the FDA ’ s definition of a cosmetic product, an article applied to the human consistency 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 rehearse, not accepted checkup evidence. not FDA evaluated.
Please lecture to your provider for extra information .