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Xclose expand Important Safety 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.

IMPORTANT SAFETY INFORMATION

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or 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. If this happens, do not drive a car, operate machinery, or do other dangerous activities

The dose of BOTOX® Cosmetic is not the same as, or comparable to, another 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.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or 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 amyotrophic lateral sclerosis (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, such as 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 breast-feed (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.

Especially 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 (be sure your doctor knows 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: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

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.

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 the 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 will gradually return to previous appearance.

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

Please see LATISSE® full Product Information.

JUVÉDERM® XC and JUVÉDERM VOLUMA® XC Important Information

APPROVED USES

JUVÉDERM® XC injectable gel is injected into areas of facial tissue where moderate to severe facial wrinkles and folds occur to temporarily add volume to skin, especially around the nose and mouth.

JUVÉDERM VOLUMA® XC injectible gel is for deep injection in the cheek area to correct age-related volume loss in adults over the age of 21.

IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM® XC or JUVÉDERM VOLUMA® XC?
Do not use these products if you have a history of multiple sever allergies or severe allergic reactions (anaphylaxis), or if you are allergic to the proteins (gram-positive bacterial proteins) used to make the hyaluronic acid (HA) in these products. Do not use JUVÉDERM® XC or JUVÉDERM VOLUMA® XC if you are allergic to lidocaine.

What precautions should my healthcare professional advise me about?

  • The safety of JUVÉDERM® XC and JUVÉDERM VOLUMA® XC injectible gels for use during pregnancy or in women who are breastfeeding has not been studied.
  • The safety of JUVÉDERM® XC for use in patients under 18 years and JUVÉDERM VOLUMA® XC for patients under 35 years or over 65 years has not been studied.
  • The safety and effectiveness of JUVÉDERM® XC for treatment of areas other than facial wrinkles and folds (such as lips) have not been established in clinical studies.
  • The safety and effectiveness of JUVÉDERM VOLUMA® XC for treatment in areas other than the cheek area have not been established in clinical studies.
  • The safety of JUVÉDERM® XC and JUVÉDERM VOLUMA® XC in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied, and use may result in additional scars or changes in pigmentation.
  • The safety of JUVÉDERM VOLUMA® XC in patients with very thin skin in the cheek area and the safety of repeat treatments in patients has not been studied.
  • There is a possible risk of inflammation at the treatment site if laser procedures and chemical peeling 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 healthcare professional if you are on therapy used to decrease the body's immune response (immunosuppressive therapy). Use of these products may result in an increased risk of infection.
  • Tell your healthcare professional if you are using medications that can prolong bleeding, such as asprin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site.
  • Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment with JUVÉDERM VOLUMA® XC.
What are possible side effects?

For JUVÉDERM® XC, most side effects are mild or moderate in nature, and last 7 days or less. The most common side effects include temporary injection-site reactions such as: redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration.

For JUVÉDERM VOLUMA® XC, side effects are moderate (uncomfortable), and generally last 2 to 4 weeks. The most common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.

As with all skin-injection procedures, there is a risk of infection.

To report a side effect with JUVÉDERM® XC or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see www.juvederm.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® XC and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.

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