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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

Do not use LATISSE® if you are allergic to one of its ingredients. 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.

These are not all the possible side effects of LATISSE®. For more information, please talk to your doctor.

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 moderate to severe forehead lines, 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. 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, and/or forehead lines.

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 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), 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; have 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 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®, 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 eyebrows, 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® Injectable Gel Fillers Important Information

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 and JUVÉDERM VOLLURE™ 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 is 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 for correction of perioral lines 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 VOLUMA® XC in patients under 35 years or over 65 years, the safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years, and the safety of JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied
  • The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral 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 commonly reported side effects with JUVÉDERM® injectable gels included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM VOLBELLA® XC, dryness was also reported. For JUVÉDERM VOLUMA® XC, most side effects were moderate and lasted 2 to 4 weeks. For JUVÉDERM® XC, JUVÉDERM VOLLURE™ XC, and JUVÉDERM® Ultra XC injectable gels, most side effects were mild or moderate and lasted 14 days or less. For JUVÉDERM VOLBELLA® XC, most side effects were mild or moderate and lasted 30 days or less.

One of the risks with using these products 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 any JUVÉDERM® product, please call Allergan at 1-800-433-8871. Please visit Juvederm.com or talk to your doctor for more information.

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.

IMPORTANT SAFETY INFORMATION
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.

PHYSICIAN PANEL See how doctors who prescribe LATISSE® answer some of the most frequently asked questions.
  • Dr. Boyd
    Plastic Surgeon
    Detroit, MI
  • Dr. Cohen
    Dermatologist
    Denver, CO
  • Dr. Downie
    Dermatologist
    Montclair, NJ
  • Dr. Lee
    Oculoplastic Surgeon
    Miami, FL
  • Dr. McDonald
    Ophthalmologist
    Lynbrook, NY
  • Dr. Moradi
    Plastic Surgeon
    Vista, CA
  • Dr. Sherman
    Oculoplastic Surgeon
    Nashville, TN
  • Dr. Wright
    Cosmetic Physician
    Dallas, TX
  • Dr. Yoelin
    Ophthalmologist
    Newport Beach, CA

HEAR FROM EXPERTS

REAL QUESTIONS, REAL ANSWERS

Real women, just like you, want to know more about LATISSE®. So we've asked doctors from around the country experienced with LATISSE® to answer the most common questions they receive about the product. Take a look at what they have to say, and if you want to know more, see the Frequently Asked Questions below.

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Does LATISSE® work?
Dr. Steve Yoelin, Ophthalmologist

Dr. Steve Yoelin, Ophthalmologist: For the majority of my patients, LATISSE® has worked well to grow their lashes, which mirrors what we saw in the LATISSE® clinical study. The lashes grow gradually over time with some people beginning to see longer lashes in about four weeks, with full growth at 16 weeks.

I participated as a clinical investigator in the LATISSE® clinical study, which was conducted at 16 sites across the country and included 278 people. Throughout the course of the 16-week treatment period, each participant was photographed and evaluated at 4-week intervals (week 0 to week 16) for differences in their overall lash prominence, including length, thickness and darkness. At the end of the 16-week treatment period, the results showed that LATISSE® was effective for 78% (107/137) of those participating vs. 18% (26/141) for those in the vehicle group (the vehicle was the same solution as LATISSE®, but without the active ingredient).

Specifically, patients treated with LATISSE® in the clinical study experienced a:

• 25% increase in lash length (vs. 2% for vehicle)
• 106% increase in lash thickness/fullness (vs. 12% for vehicle)
• 18% increase in lash darkness (vs. 3% for vehicle)

How does LATISSE® solution work?
Dr. Jeanine Downie, Dermatologist

Dr. Jeanine Downie, Dermatologist: We do not know exactly how LATISSE® works; however, we believe it does so by increasing the growth cycle (anagen) phase of your eyelash hair cycle. Anagen is the growth phase of all hair. We believe that it increases the length of the anagen phase and the number of hairs in this growth phase.

How was LATISSE® solution discovered?
Dr. Steve Yoelin, Ophthalmologist

Dr. Steve Yoelin, Ophthalmologist: It's a story of how one great product led to another. In 2001, Allergan developed another product, a medicated eye drop used to treat elevated intraocular pressure (IOP). Many patients using this medication also began to grow longer, fuller and darker lashes as a side effect. This led Allergan to study the medication's active ingredient, bimatoprost, specifically for growing lashes. After a clinical trial to study the safety and effectiveness for lash growth, LATISSE® was approved by the FDA in December of 2008.

How is LATISSE® solution different than other lash products that
        don't require a prescription?
Dr. Jeanine Downie, Dermatologist

Dr. Jeanine Downie, Dermatologist: My patients ask me this all the time. LATISSE® is the first FDA-approved product to grow lashes longer, fuller and darker for those who do not have enough lashes. It has been studied for safety and efficacy and is available only by prescription.

Why do I have to get a prescription and see a doctor to use LATISSE®?
Dr. Amir Moradi, Plastic Surgeon

Dr. Amir Moradi, Plastic Surgeon: LATISSE® is a prescription medication to grow the eyelashes longer, fuller and darker, indicated for people with inadequate or not enough lashes. LATISSE® needs to be prescribed by a doctor to assure the proper treatment and use.

What is hypotrichosis?
Dr. Charles Boyd, Plastic Surgeon

Dr. Charles Boyd, Plastic Surgeon: Eyelash hypotrichosis is the medical name for having inadequate or not enough lashes. Eyelash hypotrichosis is defined as having lower than average length, thickness and/or number of eyelashes.

How do I use LATISSE®?
Dr. Amir Moradi, Plastic Surgeon

Dr. Amir Moradi, Plastic Surgeon: LATISSE® is a treatment you apply yourself each evening to the base of the upper eyelashes. Each LATISSE® kit contains detailed instructions for proper application. You can also watch a video demonstration in the How-to-Apply section of this website.

I tell my patients to remove any makeup, clean the upper eyelids and remove their contact lenses, if applicable. Contact lenses can be placed back in the eye after 15 minutes following the application of LATISSE®. Then, using the single-use applicator brush provided in the package, one drop of LATISSE® is placed on the applicator brush and applied to the base of the upper eyelid lash margin (DO NOT APPLY in your eye or the lower lash line as excess hair growth outside the treatment area may occur). The same process is repeated using a fresh applicator brush to avoid cross contamination. Be careful not to allow the tip of the bottle or applicator to contact surrounding structures, fingers or any other unintended surface in order to avoid contamination by common bacteria known to cause infections. After applying, any excess fluid should be blotted off with a tissue. For best results, LATISSE® needs to be used once a day for 16 weeks. Using LATISSE® more than once a day will not grow your lashes faster or improve the effectiveness of the product.

What are the potential side effects? Have you seen any with
        your patients?
Dr. Wendy Lee, Oculoplastic Surgeon

Dr. Wendy Lee, Oculoplastic Surgeon: The most common side effects after using LATISSE® solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients in the clinical study. LATISSE® solution may cause other less common side effects, which typically occur on the skin close to where LATISSE® is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes and redness of the eyelids.

If LATISSE® patients develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of LATISSE® solution.

In my practice, most of my patients tolerate LATISSE® well. The adverse events I have seen in some of my patients, such as itchy eyes and eye redness, are consistent with those most commonly reported in the LATISSE® clinical trial. I also conducted my own clinical study at the Bascom Palmer Eye Institute. Adverse events reported in my study were the same as those seen in the Allergan clinical trials.

Can LATISSE® change my eye color?
Dr. Marguerite McDonald, Ophthalmologist

Dr. Marguerite McDonald, Ophthalmologist: This is one of the most common questions I get asked. LATISSE® use may cause increased brown iris pigmentation of the colored part of the eye which is likely to be permanent. While very infrequent, increased iris pigmentation has occurred when LATISSE® solution was administered. Do not apply LATISSE® in your eye or to the lower lid. Ask your doctor for complete application instructions.

Can LATISSE® solution darken my eyelids?
Dr. Joel Cohen, Dermatologist

Dr. Joel Cohen, Dermatologist: While this is a common concern, eyelid skin darkening is actually a less common side effect. In a study for FDA approval, localized skin darkening only occurred in approximately 2.9% of patients using LATISSE®. It’s caused by an increase in melanin close to where the solutiuon is applied and is expected to reverse several weeks to months after discontinuing use of the product.

Can LATISSE® harm my eyes?
Dr. Marguerite McDonald, Ophthalmologist

Dr. Marguerite McDonald, Ophthalmologist: LATISSE® is an ophthalmic solution. If any solution gets into the eye, it is not expected to cause harm. You do not need to rinse your eyes. LATISSE® is not an eye drop. DO NOT APPLY in your eye or to the lower lid.

I've heard some people use different brushes than those that
        come with LATISSE® solution. Is that OK?
Dr. Deborah Sherman, Oculoplastic Surgeon

Dr. Deborah Sherman, Oculoplastic Surgeon: No. LATISSE® is packaged with sterile applicators.

Should I wait to use LATISSE® solution until it has been around for
        a bit longer?
Dr. Steve Yoelin, Ophthalmologist

Dr. Steve Yoelin, Ophthalmologist: If you are interested in trying LATISSE®, there is no reason to wait to talk to your doctor. After clinical studies conducted by a team of 16 experienced doctors from all over the country, LATISSE® received approval from the FDA in December 2008 as the first prescription treatment to grow lashes longer, fuller and darker. And since then, approximately 8.7 million kits of LATISSE® have been sold.

I participated in the LATISSE® clinical study and have prescribed LATISSE® frequently for my patients with inadequate lashes who want to grow their lashes. Similar to the 16-week clinical study results, LATISSE® has worked well in growing lashes longer, fuller and darker for the majority of my patients.

How soon will I see results?
Dr. Deborah Sherman, Oculoplastic Surgeon

Dr. Deborah Sherman, Oculoplastic Surgeon: I tell my patients that they need to be patient when using LATISSE® as the growth is gradual over time. Some may start to notice longer lashes after about a month and many should experience full results in approximately four months. This is similar to the clinical trial results, but individual results may vary. Just like it takes some time for LATISSE® to work, if use of LATISSE® is discontinued, eyelashes will return to their previous appearance over the course of several weeks to months.

What should I do if I experience eye redness or itching?
Dr. Joel Cohen, Dermatologist

Dr. Joel Cohen, Dermatologist: Eye redness and itching sometimes occur with the use of LATISSE®. I was an investigator in the LATISSE® clinical trial for FDA approval, and eye redness and irritation occurred in approximately 4% of patients. If the redness or itching persists (or if you notice other symptoms), you should consult your doctor. If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately seek your physician’s advice concerning the continued use of LATISSE® solution.

Why do the directions say to only apply LATISSE® solution to the
        base of the upper eyelashes?
Dr. Fiona Wright, Cosmetic Physician

Dr. Fiona Wright, Cosmetic Physician: LATISSE® was only studied with patients who applied it to the upper lashes, so DO NOT APPLY in your eye or to the lower lid. It's important to apply the product appropriately, as there is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with the skin surface. I tell my patients to use the sterile applicator brushes that come with LATISSE®, and to apply the product carefully, and blot any excess solution to avoid having the solution run on the cheek or other skin areas.

Do I really have to use LATISSE® daily?
Dr. Deborah Sherman, Oculoplastic Surgeon

Dr. Deborah Sherman, Oculoplastic Surgeon: Yes, LATISSE® should be applied daily to the base of the upper eyelashes. To achieve the full effect of longer, fuller and darker lashes, you should use the product daily for 16 weeks.

What happens if I stop using LATISSE® solution?
Dr. Joel Cohen, Dermatologist

Dr. Joel Cohen, Dermatologist: Just like it takes some time for LATISSE® to work to grow lashes, if you stop using the product, your eyelashes will gradually return to their previous appearance over the course of several weeks to months.

What if I forget to apply one night? Or a few nights?
Dr. Charles Boyd, Plastic Surgeon

Dr. Charles Boyd, Plastic Surgeon: If you miss an application or a few, don't try to catch up. You don't want to double up on your treatments. Just apply the LATISSE® treatment the next evening and restart your schedule.

Is LATISSE® a replacement for mascara?
Dr. Fiona Wright, Cosmetic Physician

Dr. Fiona Wright, Cosmetic Physician: LATISSE® does not work in place of mascara, but rather is a treatment to grow lashes for those with inadequate or not enough lashes and requires a prescription from a doctor. Many of my LATISSE® patients still use mascara.

Can I use LATISSE® solution if I wear contacts?
Dr. Marguerite McDonald, Ophthalmologist

Dr. Marguerite McDonald, Ophthalmologist: Yes, but you should take them out before applying LATISSE®. Just remove your contact lenses and then wait for 15 minutes after applying LATISSE® before putting your contacts back in.

Can men use LATISSE® solution?
Dr. Amir Moradi, Plastic Surgeon

Dr. Amir Moradi, Plastic Surgeon: Both men and women can use LATISSE® to increase the length, thickness and darkness of the eyelashes if a doctor determines they are appropriate candidates for treatment. I actually have several male patients who use LATISSE® to grow their lashes and are happy with their lash results.

Is there anyone who should not use LATISSE®?
Dr. Wendy Lee, Oculoplastic Surgeon

Dr. Wendy Lee, Oculoplastic Surgeon: LATISSE® is not appropriate for people who are allergic to bimatoprost or any other ingredient in the product. If you are under care for glaucoma, notify your ophthalmologist that you are using LATISSE®. As noted in the LATISSE® product label, people using medications for the treatment of any eye pressure problems should only use LATISSE® under close doctor care. Also, anyone with known or suspected active eye disease, or anyone who is at risk for eye disorders, should check with an eye doctor before using LATISSE®.

How much does LATISSE® solution cost?
Dr. Fiona Wright, Cosmetic Physician

Dr. Fiona Wright, Cosmetic Physician: One LATISSE® kit costs approximately $120. It includes one bottle and 30 pairs of applicators. The price may vary slightly by pharmacy and, in some states, you can purchase LATISSE® directly from your doctor's office. For more ways to save, join the Allē Program to get updates on special discounts and promotions. Also, ask your doctor whether he or she offers any additional discounts or knows of any local events that may offer discounts.

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FREQUENTLY ASKED QUESTIONS

Want to know more? Here are the answers to some other common questions.

QUESTION: What are the ingredients in LATISSE® solution?
ANSWER: Active ingredient: bimatoprost.
Inactive ingredient: benzalkonium chloride; sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 – 7.8.
QUESTION: Which type of doctor prescribes LATISSE® solution?
ANSWER: Many different types of doctors can prescribe LATISSE®, including dermatologists, plastic surgeons, ophthalmologists, OB/GYNs and primary care doctors. However, not all doctors may be familiar with it. To find one who is, use the Find-A-Provider tool.
QUESTION: If I apply more LATISSE®, will I get faster results?
ANSWER: No. LATISSE® works gradually over the 16-week treatment period. Use of LATISSE® more than once a day will not increase the growth of eyelashes. Please follow the directions, as instructed by your doctor.
QUESTION: How do I maintain my results?
ANSWER: To achieve the full effect of LATISSE®, you will need to use the product daily for 16 weeks. After that point, you can talk to your doctor about ongoing use.
QUESTION: Are the lashes in the Before & After LATISSE® photos retouched?
ANSWER: The results you see posted in all of our Before & After Galleries are real photographs of actual LATISSE® users without mascara.Their lashes have not been retouched or altered in any way.
QUESTION: Are there any special warnings associated with LATISSE® use?
ANSWER: LATISSE® solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes. Refer to the illustration below. DO NOT APPLY to the lower eyelid. If you are using other products in the same class for elevated intraocular pressure (IOP), or if you have a history of abnormal IOP, you should only use LATISSE® under the close supervision of your physician.
LATISSE® solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes
LATISSE® use may cause darkening of the eyelid skin which may be reversible. LATISSE® use may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent. While very infrequent, increased iris pigmentation has occurred when LATISSE® was administered.

It is possible for hair growth to occur in other areas of your skin that LATISSE® frequently touches. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material to reduce the chance of this from happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation (darkness), number of eyelash hairs, and/or direction of eyelash growth to occur between eyes (e.g., results may vary for each eye). These differences, should they occur, will usually go away if you stop using LATISSE®.
QUESTION: What should I do if I get LATISSE® solution into my eye?
ANSWER: LATISSE® solution is an ophthalmic drug product. If any gets into the eye, it is not expected to cause harm. The eye does not need to be rinsed.
QUESTION: What is elevated intraocular pressure (IOP)?
ANSWER: This is a condition where the pressure inside the eye is higher than normal. LATISSE® may decrease IOP. So talk to your doctor if you are using IOP-lowering medications. Concurrent administration of LATISSE® and certain IOP-lowering medications in ocular hypertensive patients should be closely monitored for changes in intraocular pressure.
QUESTION: What is Allergan?
ANSWER: Allergan is a leader in the pharmaceutical industry, with over 60 years of eye care expertise.
 

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

Do not use LATISSE® if you are allergic to one of its ingredients. 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.

These are not all the possible side effects of LATISSE®. For more information, please talk to your doctor.

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 moderate to severe forehead lines, 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. 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, and/or forehead lines.

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 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), 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; have 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 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®, 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 eyebrows, 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® Injectable Gel Fillers Important Information

APPROVED USES
JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 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® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21.

JUVÉDERM® Ultra XC injectable gel 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® 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?

  • Minimize strenuous exercise and exposure to extensive sun or heat 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 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® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of 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
  • JUVÉDERM® VOLUMA® XC is intended for use in the chin and cheek areas. JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC are intended for use in facial wrinkles and folds. JUVÉDERM® VOLBELLA® XC and JUVÉDERM® Ultra XC are intended for use in the lips and perioral area. The safety and effectiveness for treatment in other areas have not been established in clinical studies
  • Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM® products has not been studied in these patients and may result in additional scars or changes in pigmentation
  • Tell your doctor if you are on therapy used to decrease the body's immune response (immunosuppressive therapy). Use may result in an increased risk of infection
  • Tell your doctor before treatment if you are using substances that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners. As with any injection, this may result in increased bruising or bleeding at the injection site
  • Patients who experience skin injury near the site of injection may be at a higher risk for adverse events
  • 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

What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. For JUVÉDERM® VOLUMA® XC, most side effects resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels, most resolved within 14 days or less. For JUVÉDERM® VOLBELLA® XC, most resolved within 30 days or less. These side effects are consistent with other facial injection procedures.

Most side effects will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).

One of the risks with these products is 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.

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

Visit Juvederm.com or talk to your doctor for more information. To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871.

Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.

Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES

    Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.

    Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.

    Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.

Who can get breast implants?
Natrelle® Breast Implants are approved for the following:

  • Breast augmentation for women at least 22 years old for silicone-filled implants and for women at least 18 years old for saline-filled implants. Breast augmentation includes primary breast augmentation to increase the breast size and revision surgery to correct or improve the result of a primary breast augmentation
  • Breast reconstruction. This includes primary breast 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. This also includes revision surgery to correct or improve the result of a primary breast reconstruction

Who should NOT get breast implants?

Breast implant surgery should NOT be performed in:

  • Women with active infection anywhere in their body
  • Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions
  • Women who are currently pregnant or nursing

What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:

  • Autoimmune diseases (eg, lupus and scleroderma)
  • A weakened immune system (eg, taking medications to decrease the body’s immune response)
  • Planned chemotherapy or radiation therapy following breast implant placement
  • Conditions or medications that interfere with wound healing and blood clotting
  • Reduced blood supply to breast tissue
  • Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders
  • Those with a diagnosis of depression or other mental health disorders should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery

What else should I consider?

  • There is a Boxed Warning for breast implants. Please see bold text at beginning
  • Many changes to your breasts following implantation are irreversible. If you later choose to have your implants removed and not replaced, you may experience dimpling, puckering, wrinkling, or other cosmetic changes, which may be permanent
  • Breast implantation is likely not a one-time surgery. The longer implants are in place, the greater the potential risk for complications. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. Thus, you should also consider the complication rates for later (revision) surgery since you may experience these risks in the future
  • Cancer treatments and surgery will affect the outcome and timing of breast reconstruction
  • Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production
  • Rupture of a silicone-filled breast implant is most often silent. Even if you have no symptoms, you should have your first ultrasound or MRI at 5 to 6 years after your initial implant surgery and then every 2 to 3 years thereafter regardless of whether your implants are for augmentation or reconstruction. If you have symptoms of or uncertain ultrasound results for breast implant rupture, an MRI is recommended. Additional imaging may be required depending on your medical history and status. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established
  • Routine screening mammography for breast cancer will be more difficult, and implants may rupture during the procedure. Perform self-examination every month for cancer screening and ask your surgeon to help you distinguish the implant from your breast tissue. Lumps, persistent pain, swelling, hardening, or changes in implant shape should be reported to your surgeon and possibly evaluated with imaging

What are key complications with breast implants?
Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility.

Talk to your doctor about other complications.

For more information, see the patient brochures at www.allergan.com/products.

To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.

The sale and distribution of Natrelle® Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery.

SkinMedica® Important Information

Most SkinMedica® products are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements here have not been evaluated by the FDA.