Approved Uses
Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of
moderate to
severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated
for injection
into the lips.
Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate
to severe
facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of
age-related
midface contour deficiencies. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal
hand to
correct volume loss.
Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.
Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.
Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to
severe facial
wrinkles and folds, such as nasolabial folds.
Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to
severe deep
facial wrinkles and folds, such as nasolabial folds. Restylane® Defyne is also indicated for injection into
the mid-to-deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin
profile in patients with mild to moderate chin retrusion.
Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies.
Restylane® Eyelight is for the improvement of infraorbital hollowing.
Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to
lidocaine or
gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder.
The
safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of
scarring
or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if
you are
planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of
inflammation at the
injection site.
Tell your doctor if you’re taking medications that lower your body’s immune response or affect bleeding, such
as
aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection
site. Using
these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be
postponed
until healing is complete.
The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation,
itching at
the injection site, and impaired hand function. Delayed-onset inflammation near the site of dermal filler
injections is
one of the known adverse events associated with dermal fillers, and cases have been reported to occur at the
dermal
filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental
procedures. Typically,
the reported inflammation was responsive to treatment or resolved on its own. Serious but rare side effects
include
delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.
The risk of
unintentional injection into a blood vessel is small but can occur and could result in serious complications,
which may
be permanent including, vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the
skin.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any Restylane® product, please call Galderma Laboratories, L.P. at 1-855-425-8722.
To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.
