`
`Visine LR. Package Insert/ Prescribing Information -Drugs.com
`
`
`
`
`
`00 Drugs.com
`00 Know more. Be sure.
`
`Visine L.R.
`
`
`Package insert/
`
`prescribing information
`
`
`
`Generic name: o ymetazoline hydrochloride
`
`Dosage form: eye drops
`
`
`
`Drug class: Ophthalmic antihi tamine and deconge tant
`
`
`
`
`
`
`
`Medically reviewed by Drug com La t updated on Mar 22, 2022
`
`On This Page
`
`
`
`Indications and Usage
`
`Warnings
`
`Dosage and Administration
`
`Drug Facts
`
`Active ingredient
`
`
`
`Oxymetazoline HCI O 025%
`
`Purpose
`
`Redness reliever
`
`Use
`
`
`
`
`
`•for the relief of redness of the eye due to minor eye irritations
`
`Warnings
`
`Ask a doctor before use if you have narrow angle glaucoma.
`
`When using this product
`
`
`
`•overuse may cause more eye redness
`
`
`
`•remove contact lenses before using
`
`
`
`•do not use if this solution changes color or becomes cloudy
`
`
`
`•do not touch tip of container to any surface to avoid contamination
`
`
`
`1/4
`
`Eye Therapies Exhibit 2193, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Visine L.R. Package Insert / Prescribing Information - Drugs.com
`
`replace cap after each use
`
`Stop use and ask a doctor if
`
`you feel eye pain
`
`changes in vision occur
`
`redness or irritation of the eye lasts
`
`condition worsens or lasts more than 72 hours
`
`If pregnant or breast-feeding, ask a health professional before use.
`
`Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right
`away.
`Directions
`adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s)
`
`this may be repeated as needed every 6 hours or as directed by a doctor
`
`children under 6 years of age: ask a doctor
`
`Other information
`store at 15° to 25°C (59° to 77°F)
`
`Inactive ingredients
`benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride
`Questions?
`call 1-888-734-7648, weekdays
`PRINCIPAL DISPLAY PANEL - 15 mL Carton
`LONG
`LASTING
`REDNESS
`RELIEF
`
`Sterile
`Visine ®
`
`2/4
`
`Eye Therapies Exhibit 2193, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Visine L.R. Package Insert / Prescribing Information - Drugs.com
`
`L.R.
`
`®
`
`LONG-LASTING
`REDNESS RELIEF
`
`OXYMETAZOLINE HCl
`REDNESS RELIEVER EYE DROPS
`
`Gets The Red Out
`®
`
`Up To 6 Hours Relief
`
`1/2 FL OZ(15 mL)
`
`VISINE L R
`oxymetazoline hydrochloride liquid
`
`Product Information
`
`Product Type
`
`HUMAN OTC DRUG
`
`Item Code (Source)
`
`NDC:42002-204
`
`3/4
`
`Eye Therapies Exhibit 2193, 3 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Route of Administration
`
`Visine L.R. Package Insert / Prescribing Information - Drugs.com
`DEA Schedule
`OPHTHALMIC
`
`Active Ingredient/Active Moiety
`
`Ingredient Name
`
`Basis of Strength
`
`Strength
`
`Oxymetazoline Hydrochloride (Oxymetazoline)
`
`Oxymetazoline Hydrochloride
`
`0.25 mg in 1 mL
`
`Packaging
`
`#
`
`Item Code
`
`Package Description
`
`1 NDC:42002-204-05
`
`1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
`
`1
`
`15 mL in 1 BOTTLE, PLASTIC
`
`2 NDC:42002-204-35
`
`1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
`
`2
`
`20 mL in 1 BOTTLE, PLASTIC
`
`3 NDC:42002-204-01
`
`1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
`
`3
`
`30 mL in 1 BOTTLE, PLASTIC
`
`Marketing Information
`
`Marketing
`Category
`
`NDA
`
`Application Number or Monograph Citation Marketing Start Date Marketing End Date
`
`NDA019407
`
`04/05/2010
`
`Labeler - Johnson & Johnson Healthcare Products Inc., Division of McNEIL-PPC, Inc. (831417154)
`
`Johnson & Johnson Healthcare Products Inc., Division of McNEIL-PPC, Inc.
`
`4/4
`
`Eye Therapies Exhibit 2193, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`