LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information

Approved Use

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 Product Information.

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Approved Uses

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.

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, 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: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids and eyebrows, 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.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.

JUVÉDERM® Collection of Fillers Important Information

INDICATIONS

JUVÉDERM® VOLUMA™ XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.

JUVÉDERM® VOLLLURE™ XC 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) in adults over the age of 21.

JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

JUVÉDERM® VOLBELLA™ XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.

JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.

WARNINGS

Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. 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: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur

Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled

PRECAUTIONS



To minimize the risk of potential complications, these products should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy and product use in indicated areas

The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications

The safety and effectiveness for the treatment of anatomic regions other than the mid-face, chin, and prejowl sulcus regions with JUVÉDERM ® VOLUMA ™ XC; facial wrinkles and folds with JUVÉDERM ® VOLLURE ™ XC, JUVÉDERM ® Ultra Plus XC, and JUVÉDERM ® Ultra XC; and the lips and perioral area with JUVÉDERM ® VOLBELLA ™ XC and JUVÉDERM ® Ultra XC have not been established in controlled clinical studies

VOLUMA XC; facial wrinkles and folds with JUVÉDERM VOLLURE XC, JUVÉDERM Ultra Plus XC, and JUVÉDERM Ultra XC; and the lips and perioral area with JUVÉDERM VOLBELLA XC and JUVÉDERM Ultra XC have not been established in controlled clinical studies The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied

The safety for use of JUVÉDERM ® VOLUMA ™ XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation

VOLUMA XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation The safety for use of JUVÉDERM ® Ultra Plus XC and JUVÉDERM ® Ultra XC in patients under 18 years, and JUVÉDERM ® VOLLURE ™ XC and JUVÉDERM ® VOLBELLA ™ XC in patients under 22 years, has not been established

Ultra Plus XC and JUVÉDERM Ultra XC in patients under 18 years, and JUVÉDERM VOLLURE XC and JUVÉDERM VOLBELLA XC in patients under 22 years, has not been established As with all transcutaneous procedures, dermal filler implantation carries a risk of infection

Use dermal fillers with caution in patients on immunosuppressive therapy

Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites

Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events

The safety for use of JUVÉDERM ® VOLUMA ™ XC injectable gel in patients with very thin skin in the mid-face has not been established

VOLUMA XC injectable gel in patients with very thin skin in the mid-face has not been established The safety of JUVÉDERM ® VOLUMA ™ XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI

VOLUMA XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI JUVÉDERM ® VOLUMA ™ XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study

VOLUMA XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study The effect of JUVÉDERM ® VOLUMA ™ XC injection into the chin on facial hair growth has not been studied

VOLUMA XC injection into the chin on facial hair growth has not been studied Patients may experience late onset nodules with use of dermal fillers including JUVÉDERM ® VOLUMA ™ XC

VOLUMA XC Patients may experience late onset adverse events with use of dermal fillers

ADVERSE EVENTS

The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA™ XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA™ XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE™ XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA™ XC, most resolved within 30 days.

To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan at 1-800-433-8871. Please visit JuvedermDFU.com for more information.

Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.

Natrelle® Breast Implants Important Information

Who may get breast implants (INDICATIONS)?

Natrelle® Breast Implants are approved 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.



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. Breast reconstruction. Breast reconstruction includes primary 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. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

IMPORTANT SAFETY INFORMATION

Who should NOT get breast implants (CONTRAINDICATIONS)?

Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.

What else should I consider (WARNINGS)?

Breast implants are not lifetime devices or necessarily a one-time surgery. 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 produce milk for breastfeeding. Silicone-filled implants may rupture without symptoms. You should have MRI examinations 3 years after surgery and then every 2 years thereafter in order to detect ruptures. 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. Talk to your doctor about removing ruptured implants. Inform any other doctor if you have 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, a weakened immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder or eating disorders. These disorders should be resolved or stabilized prior to 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.