`
`VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops
`Johnson & Johnson Consumer Inc.
`
`Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and
`policies. FDA has not evaluated whether this product complies.
`
`----------
`
`Visine® Original Redness Relief
`Eye Drops
`
`Drug Facts
`
`Active ingredients
`
`Tetrahydrozoline HCl 0.05%
`
`Purpose
`
`Redness reliever
`
`Use
`
`for the relief of redness of the eye due to minor eye irritations
`
`Warnings
`
`For external use only.
`
`Ask a doctor before use if you have narrow angle glaucoma.
`When using this product
`
`pupils may become enlarged temporarily
`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
`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
`
`put 1 to 2 drops in the affected eye(s) up to 4 times daily
`children under 6 years of age: ask a doctor
`
`Other information
`
`store at 15° to 25°C (59° to 77°F)
`
`1/4
`
`Eye Therapies Exhibit 2194, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Inactive ingredients
`
`Visine® Original Redness Relief Eye Drops
`
`benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride
`
`Questions?
`
`call toll-free 888-734-7648 or 215-273-8755 (collect)
`
`Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558 USA
`
`PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
`
`Sterile
`Visine®
`
`ORIGINAL
`Redness Relief
`TETRAHYDROZOLINE HCl
`REDNESS RELIEVER EYE DROPS
`
`Gets the
`Red Out®
`
`Fast-acting
`formula
`
`1/2 FL OZ (15mL)
`
`2/4
`
`Eye Therapies Exhibit 2194, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Visine® Original Redness Relief Eye Drops
`
`VISINE ORIGINAL REDNESS RELIEF
`tetrahydrozoline hydrochloride solution/ drops
`Product Information
`Product Type
`Route of Administration
`Active Ingredient/Active Moiety
`
`HUMAN OTC DRUG
`OPHTHALMIC
`
`Ingredient Name
`Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline -
`UNII:S9U025Y077)
`Inactive Ingredients
`
`Item Code (Source)
`
`NDC:42002-203
`
`Basis of Strength
`Tetrahydrozoline
`Hydrochloride
`
`Strength
`
`0.5 mg in 1 mL
`
`Ingredient Name
`
`Strength
`
`Benzalkonium Chloride (UNII: F5UM2KM3W7)
`Boric Acid (UNII: R57ZHV85D4)
`Edetate Disodium (UNII: 7FLD91C86K)
`Water (UNII: 059QF0KO0R)
`
`3/4
`
`Eye Therapies Exhibit 2194, 3 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Sodium Borate (UNII: 91MBZ8H3QO)
`Sodium Chloride (UNII: 451W47IQ8X)
`
`Visine® Original Redness Relief Eye Drops
`
`Packaging
`#
`Item Code
`1 NDC:42002-
`203-02
`
`1
`2 NDC:42002-
`203-35
`
`2
`
`Package Description
`
`1 in 1 CARTON
`
`15 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise
`Combined with Drug
`
`Marketing Start
`Date
`
`Marketing End
`Date
`
`10/01/2009
`
`09/30/2022
`
`1 in 1 CARTON
`
`10/01/2009
`
`08/31/2016
`
`19 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise
`Combined with Drug
`
`Marketing Information
`Application Number or Monograph Citation
`Marketing Category
`part349
`OTC MONOGRAPH FINAL
`Labeler - Johnson & Johnson Consumer Inc. (002347102)
`
`Marketing Start Date
`10/01/2009
`
`Marketing End Date
`09/30/2022
`
`Revised: 9/2020
`Document Id: 3a707756-04d2-46e0-a2f6-c1425fecb2aa
`Set id: e3c41a58-fc93-4e6c-99be-0529edfb54a4
`Version: 9
`Effective Time: 20200922
`
`Johnson & Johnson Consumer Inc.
`
`4/4
`
`Eye Therapies Exhibit 2194, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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