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JUVÉDERM XC Indication and Important Safety Information

INDICATION

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

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
• In order to minimize the risk of potential complications, JUVÉDERM Ultra XC and JUVÉDERM® Ultra Plus XC injectable gels should only be used by
healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy
• Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients
are aware of signs and symptoms of potential complications
• The safety and effectiveness for the treatment of anatomic regions other than moderate to severe facial wrinkles and folds with JUVÉDERM XC, and the
lips and perioral area for lip augmentation with JUVÉDERM Ultra XC, have not been established in controlled clinical studies
• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials
• The safety for use during pregnancy, in breastfeeding females, and in patients under 18 years has not been established
• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• Use 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

ADVERSE EVENTS
The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration,
and itching. Most side effects are mild or moderate in nature, lasting 14 days or less.
To report a problem with JUVÉDERM® Ultra XC or JUVÉDERM Ultra Plus XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC injectable gels are available by prescription only.

JUVÉDERM XC Before-and-After Photo Files

Juvederm XC before and after photos (Jennifer)

Actual patient. Results may vary. Unretouched photos taken before treatment and 2 weeks after treatment with JUVÉDERM XC. A total of
3.0 mL of JUVÉDERM XC was injected into the parentheses, marionette, and corner, and vertical lip lines

APPROVED USES

JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related
volume loss in adults over 21.
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.
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 in 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, 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 Juvederm.com or call Allergan Medical
Information at 1-800-433-8871.
Available by prescription only.

Juvederm XC before and after photos (Laura)

Actual patient. Results may vary. Unretouched photos taken before treatment and 2 weeks after treatment with JUVÉDERM XC. A total of
3.0 mL of JUVÉDERM XC was injected into the parentheses, marionette, and corner, and vertical lip lines.

APPROVED USES

JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related
volume loss in adults over 21.
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.
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 in 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, 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 Juvederm.com or call Allergan Medical
Information at 1-800-433-8871.
Available by prescription only.

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241 Golf Mill Center #405,
Niles, Illinois 60714

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Phone: (312) 972-6236

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