Eye Therapies Exhibit 2096, 1 of 6
`Slayback v. Eye Therapies - IPR2022-00142
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`Slayback v. Eye Therapies - IPR2022-00142
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`8/16/22, 11:04 AM
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`DailyMed - VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops
`for the relief of redness of the eye due to minor eye irritations
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`CLOSE
`
`WARNINGS
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`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
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`you feel eye pain
`changes in vision occur
`redness or irritation of the eye lasts
`condition worsens or lasts more than 72 hours
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`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.
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`CLOSE
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`DIRECTIONS
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`put 1 to 2 drops in the affected eye(s) up to 4 times daily
`children under 6 years of age: ask a doctor
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`CLOSE
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`OTHER INFORMATION
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`store at 15° to 25°C (59° to 77°F)
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`CLOSE
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`INACTIVE INGREDIENTS
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`benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride
`
`CLOSE
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`QUESTIONS?
`
`https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c41a58-fc93-4e6c-99be-0529edfb54a4
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`2/6
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`Eye Therapies Exhibit 2096, 2 of 6
`Slayback v. Eye Therapies - IPR2022-00142
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`
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`DailyMed - VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops
`8/16/22, 11:04 AM
`call toll-free 888-734-7648 or 215-273-8755 (collect)
`
`CLOSE
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`SPL UNCLASSIFIED SECTION
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`Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558 USA
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`CLOSE
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`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)
`
`https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c41a58-fc93-4e6c-99be-0529edfb54a4
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`3/6
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`Eye Therapies Exhibit 2096, 3 of 6
`Slayback v. Eye Therapies - IPR2022-00142
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`
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`8/16/22, 11:04 AM
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`DailyMed - VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops
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`CLOSE
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`INGREDIENTS AND APPEARANCE
`
`VISINE ORIGINAL REDNESS RELIEF
`tetrahydrozoline hydrochloride solution/ drops
`
`PRODUCT INFORMATION
`
`
`
`
`
`
`
`Product Type
`Route of Administration
`
`HUMAN OTC DRUG
`OPHTHALMIC
`
`Item Code (Source)
`
`NDC:42002-203
`
`
`ACTIVE INGREDIENT/ACTIVE MOIETY
`
`Ingredient Name
`Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D)
`(Tetrahydrozoline - UNII:S9U025Y077)
`
`Basis of Strength
`Tetrahydrozoline
`Hydrochloride
`
`Strength
`0.5 mg
` in 1 mL
`
`https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c41a58-fc93-4e6c-99be-0529edfb54a4
`
`4/6
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`Eye Therapies Exhibit 2096, 4 of 6
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`8/16/22, 11:04 AM
`
`DailyMed - VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops
`
`INACTIVE INGREDIENTS
`
`Ingredient Name
`Benzalkonium Chloride (UNII: F5UM2KM3W7)
`Boric Acid (UNII: R57ZHV85D4)
`Edetate Disodium (UNII: 7FLD91C86K)
`Water (UNII 059QF0KO0R)
`Sodium Borate (UNII: 91MBZ8H3QO)
`Sodium Chloride (UNII: 451W47IQ8X)
`
`Strength
`
`
`
`
`
`
`
`
`PACKAGING
`
`#
`
`1
`
`1
`
`2
`
`2
`
`Item Code
`
`Package Description
`
`NDC 42002
`203-02
`
`1 in 1 CARTON
`
`Marketing
`Start Date
`10/01/2009
`
`Marketing End
`Date
`09/30/2022
`
`NDC:42002-
`203 35
`
`15 mL in 1 BOTTLE,
`DROPPER; Type 4: Device
`Coated/Impregnated/Otherwise
`Combined with Drug
`1 in 1 CARTON
`
`19 mL in 1 BOTTLE,
`DROPPER; Type 4: Device
`Coated/Impregnated/Otherwise
`Combined with Drug
`
`10/01/2009
`
`08/31/2016
`
`MARKETING INFORMATION
`
`Marketing Category
`
`OTC MONOGRAPH
`FINAL
`
`Application Number or
`Monograph Citation
`part349
`
`Marketing Start
`Date
`10/01/2009
`
`Marketing End
`Date
`09/30/2022
`
`LABELER - JOHNSON & JOHNSON CONSUMER INC. (002347102)
`
`CLOSE
`
`CLOSE ALL SECTIONS
`
`https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c41a58-fc93-4e6c-99be-0529edfb54a4
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`5/6
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`Eye Therapies Exhibit 2096, 5 of 6
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`8/16/22, 11:04 AM
`
`DailyMed - VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops
`
`FIND ADDITIONAL RESOURCES (also available in the left menu)
`SAFETY
`Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
`
`RELATED RESOURCES
`Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
`
`MORE INFO ON THIS DRUG
`View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
`
`
`
`https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c41a58-fc93-4e6c-99be-0529edfb54a4
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`6/6
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`Eye Therapies Exhibit 2096, 6 of 6
`Slayback v. Eye Therapies - IPR2022-00142
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