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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

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.

To report a side effect, please call Allergan at 1-800-433-8871.

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 both moderate to severe crow’s feet lines and frown lines between the eyebrows in adults.

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
  • 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, or both at the same time.

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 take 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; weakness of forehead muscles: 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 nonprescription medicines, vitamins, and herbal products. 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 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 VOLUMA® XC, JUVÉDERM® XC, and JUVÉDERM® Ultra XC Important Information

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.

Do not use if you have a history of severe allergies/allergic reactions, or are allergic to lidocaine or gram-positive bacterial proteins used to make these products. The safety of use while pregnant or breastfeeding has not been studied. The safety for use in patients with excessive scarring or pigmentation disorders has not been studied and may result in additional scars or pigmentation changes. Unintentional injection into a blood vessel can occur and, while rare, could result in serious complications which may be permanent. These include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring. Tell your doctor if you are on medications to decrease the body’s immune response or prolong bleeding, such as aspirin, ibuprofen, or blood thinners. There is a risk of infection from skin injection procedures.

The most common side effects include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Most JUVÉDERM® XC side effects are mild or moderate, and last 7 days or less. Most JUVÉDERM® Ultra XC side effects are mild or moderate, and last 14 days or less. Most JUVÉDERM VOLUMA® XC side effects are moderate and last 2 to 4 weeks.

To report a side effect, 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.

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 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.

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.

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