FDA label 194326a6-ec33-4dc6-89c8-5c8393b83c3d

5 WARNINGS AND PRECAUTIONS Corneal Ulcer: Remove lenses ( 5.1 ) Contact Lens Related Complications: Remove lenses ( 5.2 ) Chemical Exposures: Flush eyes with water ( 5.3 ) Acanthamoeba Keratitis: Do not wear while swimming ( 5.4 ) 5.1 Corneal Ulcers ACUVUE Theravision with Ketotifen should not be inserted if the patient has corneal epithelial breakdown, corneal ulceration, dry eye disease, injury or abnormality that affects the eyelids or anterior segment of the eye. Contact lens wear may worsen these conditions and lead to sight threatening complications. If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of the eye, the patient should be instructed to immediately remove the lenses, and promptly contact the Eye Care Professional. Studies have shown that when daily wear users wear their lenses overnight, the risk of ulcerative keratitis is greater than among those who do not wear them overnight. Contact lens wearers who are smokers have a higher incidence of corneal ulcers than nonsmokers. 5.2 Contact Lens-Related Complications ACUVUE Theravision with Ketotifen should not be used to treat or prevent lens-related symptoms including irritation, discomfort or redness. ACUVUE Theravision with Ketotifen insertion could result in serious injury if a patient is experiencing these symptoms. Patients should be cautioned that proper use and care of contact lenses and lens care products are essential for the safe use of these products. If patients experience symptoms of contact lens intolerance or keratitis, the lens(es) should be IMMEDIATELY REMOVED. 5.3 Chemical Exposures If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 5.4 Acanthamoeba Keratitis ACUVUE Theravision with Ketotifen should not be worn while swimming or in hot tubs. The lens should not be rinsed in water from the tap. Tap water contains many impurities that can contaminate or damage the lenses and may lead to eye infection or injury. Contact lens wear in these settings increases the risk of sight threatening eye infections from microorganisms. 5.5 Backup Spectacles Eye Care Professionals should instruct the patient to always have a functional pair of spectacles with a current prescription available to use if the patient becomes unable to wear contact lenses, or in circumstances where contact lens wear is not advised. 5.6 Eye Protection Patients should be advised to notify the employer of being a contact lens wearer. Some jobs may require the use of eye protection equipment or may require that the patient not wear contact lenses. 5.7 Concomitant Use of Eye Drops or Eye Medications Eye Drops or Eye Medications containing benzalkonium chloride should not be used simultaneously with ACUVUE® Theravision™ with Ketotifen. Wait at least 10 minutes after eye drop application before inserting lenses.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Ocular Hyperemia [see Contraindications (4.1) ] Corneal Hypoesthesia [see Contraindications (4.2) ] Corneal Infections [see Contraindications (4.3) ] Corneal Ulcers [see Warnings and Precautions (5.1) ] Contact Lens-Related Complications [see Warning and Precautions (5.2) ] Chemical Exposure [see Warnings and Precautions (5.3) ] Acanthamoeba Keratitis [see Warnings and Precautions (5.4) ] The most commonly observed adverse reactions in clinical studies, occurring in ≥ 1% of ACUVUE ® Theravision™ with Ketotifen treated eyes, were eye irritation, eye pain, and instillation site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Johnson & Johnson Vision Care, Inc. at 1-800-843-2020 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice. The most commonly observed adverse reactions in clinical studies, occurring in ≥1% of ACUVUE ® Theravision™ with Ketotifen treated eyes, were eye irritation, eye pain, and instillation site irritation.