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, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting 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, forehead lines, and/or platysma bands.

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving 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, including 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), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products.

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 standard doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including surgery or plans to have surgery on your face, 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), or are breastfeeding 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, Xeomin, Jeuveau, Daxxify, or Letybo 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; or 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, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes.

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, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.

For more information, refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan Aesthetics at 1-800-678-1605.

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

APPROVED USES

JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss, for augmentation of the chin region to improve the chin profile, and for augmentation of the temple region to improve moderate to severe temple hollowing in adults over 21.

JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 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. Most of these events are irreversible
• If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately
• 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
• The effectiveness of removal of any dermal filler has not been studied

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, under 22 years or over 80 years for chin augmentation, and under 32 years or over 82 years for temple area augmentation. The safety of JUVÉDERM® VOLUX® XC, 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
• Avoid applying makeup for 12 hours after treatment and 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
• Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment

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 within 30 days. Your doctor may choose to treat side effects persisting longer 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.

APPROVED USES

SKINVIVE by JUVÉDERM® injectable gel is an injection to improve skin smoothness of the cheeks in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive SKINVIVE by JUVÉDERM® treatment?

Do not use this product 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 this product, or if you have had previous allergic reactions to hyaluronic acid fillers.

What Warnings should my specialist advise me about?

• One of the risks with dermal filler injection 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. Most of these events are irreversible. Tell your specialist immediately if you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment
• The use of this product where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
• The effectiveness of removal of any dermal filler has not been studied

What Precautions should my specialist advise me about?

• Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site
• Tell your specialist if you are using any medication that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site
• Tell your specialist if you are planning laser treatment, chemical peeling, or any other procedure after SKINVIVE by JUVÉDERM®. There is a possible risk of an inflammatory reaction at the treatment site
• This product is intended for improving skin smoothness of the cheeks. The safety and effectiveness for treatment in other areas of the body have not been established
• Tell your specialist if you are on therapy used to decrease the body's immune response, as treatment may result in an increased risk of infection
• Tell your specialist if you are pregnant or breastfeeding. The safety for use during pregnancy, or in women who are breastfeeding, has not been studied
• Tell your specialist if you have a history of excessive scarring (thick, hard scars). The safety of this product in patients with a history of excessive scarring has not been studied and may result in additional scars
• Tell your specialist if you have a history of pigmentation disorders, as use of this product in patients with a history of pigmentation disorders has not been studied and may result in changes in pigmentation

What are the possible side effects of treatment?

The most commonly reported side effects were redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration and itching. Most side effects will resolve within 7 days. If they persist longer, your physician may choose to treat them with medications, such as antibiotics, steroids, or hyaluronidase. Additionally, there have been reports of inflammation, nodules, unsatisfactory result, loss or lack of improvement, allergic reaction, anxiety, blood vessel blockage, infection, dry skin, increase or decrease in sensation, and abscess.

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers. As with all skin injection procedures, there is a risk of infection.

To report a side effect, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit SKINVIVE.com or talk to your specialist for more information.

SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.