INDICATIONS, IMPORTANT SAFETY INFORMATION AND PRESCRIBING INFORMATION

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indications

BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity

– Moderate to severe lateral canthal lines associated with orbicularis oculi activity

– Moderate to severe forehead lines associated with frontalis activity

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Post marketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

CONTRAINDICATIONS

BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS

Lack of Interchangeability Between Botulinum Toxin Products

The potency units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.

• Spread of Toxin Effect: Please refer to Boxed Warning for Distant Spread of Toxin Effect. No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
• Serious Adverse Reactions With Unapproved Use: Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
• Hypersensitivity Reactions: Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
• Cardiovascular System: There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
• Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders: Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
• Dysphagia and Breathing Difficulties: Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
• Pre-existing Conditions at the Injection Site: Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
• Dry Eye in Patients Treated With BOTOX® Cosmetic: There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
• Human Albumin and Transmission of Viral Diseases: This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS

The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).

The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).

The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).

DRUG INTERACTIONS

Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.

The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.

USE IN SPECIFIC POPULATIONS

There are no studies or adequate data from post marketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.

INDICATIONS

JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.

JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.

JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.

JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.

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

JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

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, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, 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

• To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
• The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
• The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
• The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
• The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
• Dermal fillers should be used with caution in patients on immunosuppressive therapy
• Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
• The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
• The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
• JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
• The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
• Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
• Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
• Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied

ADVERSE EVENTS

The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.

To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.

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

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC

INDICATIONS

SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

This product 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 this product.

WARNINGS

• Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, 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
• Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS

PRECAUTIONS

• To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
• Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
• Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
• This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
• Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
• As with all transcutaneous procedures, injections of the product carry a risk of infection
• The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
• This product should be used with caution in patients on immunosuppressive therapy
• Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
• Patients may experience late onset AEs with use of injectable gel implants, including this product
• This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site

ADVERSE EVENTS

In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.

To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.

SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed

to use LATISSE safely and effectively. See full prescribing

information for LATISSE.

LATISSE® (bimatoprost ophthalmic solution) 0.03%, for

topical ophthalmic use

Initial U.S. Approval: 2001

_________________INDICATIONS AND USAGE___________________

LATISSE® is a prostaglandin analog, indicated to treat

hypotrichosis of the eyelashes by increasing their growth

including length, thickness and darkness. (1)

_____________DOSAGE AND ADMINISTRATION______________

Apply nightly directly to the skin of the upper eyelid margin

at the base of the eyelashes using the accompanying

applicators. Blot any excess solution beyond the eyelid

margin. Dispose of the applicator after one use. Repeat for

the opposite eyelid margin using a new sterile applicator. (2)

____________DOSAGE FORMS AND STRENGTHS____________

Ophthalmic solution containing bimatoprost 0.3 mg/mL. (3)

___________________ CONTRAINDICATIONS ______________________

Hypersensitivity. (4)

___________WARNINGS AND PRECAUTIONS_______

 Concurrent administration of LATISSE® and intraocular

pressure (IOP)-lowering prostaglandin analogs in ocular

hypertensive patients may decrease the IOP-lowering

effect. Patients using these products concomitantly should

be closely monitored for changes to their IOP. (5.1)

Pigmentation of the eyelids and iris may occur. Iris

pigmentation is likely to be permanent. (5.2, 5.3)

_______________ADVERSE REACTIONS__________________

Most common adverse reactions (incidence approximately 3%

to 4%) are eye pruritus, conjunctival hyperemia, and skin

hyperpigmentation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact

Allergan at 1-800-678-1605 or the FDA at 1-800-FDA-1088

or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and

FDA-approved patient labeling (Patient Information).

Revised: 8/2021

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Effects on Intraocular Pressure

5.2 Iris Pigmentation

5.3 Lid Pigmentation

5.4 Hair Growth Outside the Treatment Area

5.5 Intraocular Inflammation

5.6 Macular Edema

5.7 Contamination of LATISSE® or Applicators

5.8 Use with Contact Lenses

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric

Do not apply to the lower eyelash line [see Warnings and Precautions (5.3, 5.4) and Patient Counseling

Information (17)].

Additional applications of LATISSE® will not increase the growth of eyelashes. Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level.

3 DOSAGE FORMS AND STRENGTHS

Ophthalmic solution containing bimatoprost 0.3 mg/mL.

4 CONTRAINDICATIONS

LATISSE® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Effects on Intraocular Pressure

Bimatoprost ophthalmic solution (LUMIGAN®) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, LATISSE® lowered IOP, however, the magnitude of the reduction was not cause for clinical concern.

In ocular hypertension studies with LUMIGAN®, it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect. In patients using LUMIGAN® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.

5.2 Iris Pigmentation. Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent [see Adverse Reactions]

(6.2). Atoprost ophthalmic solution may not be noticeable for several months to years.

Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. Treatment with LATISSE® solution can be continued in patients who develop noticeably increased iris pigmentation.

5.3 Lid Pigmentation. Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.

5.4 Hair Growth Outside the Treatment Area. There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with the skin surface. It is important to apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess LATISSE® from the eyelid margin to avoid it running onto the cheek or other skin areas.

5.5 Intraocular Inflammation LATISSE® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

5.6 Macular Edema. Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution (LUMIGAN®) for elevated IOP. LATISSE® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

5.7 Contamination of LATISSE® or Applicators. The LATISSE® bottle must be kept intact during use. It is important to use LATISSE® solution as instructed, by placing one drop on the single-use-per-eye applicator. The bottle tip should not be allowed to contact any other surface since it could become contaminated. The accompanying sterile applicators should only be used on one eye and then discarded since reuse of applicators increases the potential for contamination and infections. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products [see Patient Counseling Information (17)].

5.8 Use with contact lenses LATISSE® contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

• Effects on Intraocular Pressure [see Warnings and Precautions (5.1)]

• Iris Pigmentation [see Warnings and Precautions (5.2)]

• Lid Pigmentation [see Warnings and Precautions (5.3)]

• Hair Growth Outside the Treatment Area [see Warnings and Precautions]