NAPHCON A - naphazoline hydrochloride and pheniramine maleate solution/ drops
`Alcon Laboratories, Inc.
`
`Drug Facts
`
`----------
`
`Drug Facts
`
`Active ingredients
`Naphazoline hydrochloride
`0.025%
`Pheniramine maleate 0.3%
`
`Uses
`
`Purpose
`
`Redness reliever
`
`Antihistamine
`
`for the temporary relief of redness and itching of the eye(s) due to:
`
`ragweed
`pollen
`grass
`animal dander and hair
`
`Warnings
`
`For external use only
`
`Do not use
`
`if you are sensitive to any ingredient in this product
`if this solution changes color or becomes cloudy
`
`Ask a doctor before use if you have
`
`narrow angle glaucoma
`heart disease
`high blood pressure
`trouble urinating
`
`When using this product
`
`pupils may become enlarged temporarily causing light sensitivity
`overuse may cause more eye redness
`remove contact lenses before using
`to avoid contamination, do not touch tip of container to any surface
`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(s) gets worse or lasts more than 72 hours
`
`Keep out of the reach of children.
`
`If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and
`marked reduction in body temperature.
`
`1/11
`
`Eye Therapies Exhibit 2192, 1 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`Alcon Laboratories, Inc.
`
`Drug Facts
`
`----------
`
`Drug Facts
`
`Active ingredients
`Naphazoline hydrochloride
`0.025%
`Pheniramine maleate 0.3%
`
`Uses
`
`Purpose
`
`Redness reliever
`
`Antihistamine
`
`for the temporary relief of redness and itching of the eye(s) due to:
`
`ragweed
`pollen
`grass
`animal dander and hair
`
`Warnings
`
`For external use only
`
`Do not use
`
`if you are sensitive to any ingredient in this product
`if this solution changes color or becomes cloudy
`
`Ask a doctor before use if you have
`
`narrow angle glaucoma
`heart disease
`high blood pressure
`trouble urinating
`
`When using this product
`
`pupils may become enlarged temporarily causing light sensitivity
`overuse may cause more eye redness
`remove contact lenses before using
`to avoid contamination, do not touch tip of container to any surface
`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(s) gets worse or lasts more than 72 hours
`
`Keep out of the reach of children.
`
`If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and
`marked reduction in body temperature.
`
`1/11
`
`Eye Therapies Exhibit 2192, 1 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Directions
`
`Drug Facts
`
`adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily
`children under 6 years: ask a doctor
`
`Other information
`
`store at 20°-25°C (68°-77°F)
`protect from light
`
`Inactive ingredients
`
`benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid
`
`Questions?
`
`In the U.S. call 1-800-757-9195 or visit www.alcon.com
`
`PRINCIPAL DISPLAY PANEL
`
`NAPHCON A®
`EYE DROPS
`
`Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%
`
`Redness Reliever and Antihistamine Eye Drops
`
`Relieves Itching & Redness
`
`EYE ALLERGY RELIEF
`
`CLINICALLY PROVEN
`
`STERILE 15 mL (0.5 FL OZ)
`
`TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or
`missing at time of purchase.
`
`Actual Size
`
`Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.
`
`ALCON LABORATORIES, INC.
`6201 South Freeway
`Fort Worth, TX 76134
`
`©2002, 2008, 2014, 2015 Novartis
`
`9011949-0615
`
`Alcon®
`a Novartis company
`
`LOT:
`EXP.:
`
`2/11
`
`Eye Therapies Exhibit 2192, 2 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Drug Facts
`
`CLINICALLY PROVEN
`
`EYE ALLERGY RELIEF
`
`NAPHCON A®
`
`Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%
`
`Ophthalmic Solution
`
`Redness Reliever and Antihistamine
`
`RELIEVES ITCHING & REDNESS
`
`EYE DROPS
`
`STERILE 15 mL (0.5 FL OZ)
`
`TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or
`missing at time of purchase.
`
`Actual Size
`
`3/11
`
`Eye Therapies Exhibit 2192, 3 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Drug Facts
`
`Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.
`
`ALCON LABORATORIES, INC.
`6201 South Freeway
`Fort Worth, TX 76134 USA
`
`Alcon
`
`LOT:
`EXP.:
`
`9017142-0419
`
`EYE ALLERGY RELIEF
`
`NAPHCON A®
`
`Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%
`
`Ophthalmic Solution
`
`Redness Reliever and Antihistamine
`
`RELIEVES ITCHING & REDNESS
`
`4/11
`
`Eye Therapies Exhibit 2192, 4 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
` EYE DROPS
`
`CLINICALLY PROVEN
`
`STERILE 15 mL (0.5 FL OZ)
`
`Alcon®
`
`Drug Facts
`
`Active ingredients: Naphazoline EYE ALLERGY RELIEF Hydrochloride 0.025%, Pheniramine Maleate 0.3%.
`
`Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.
`
`DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: ask a doctor.
`
`WARNINGS: See Drug Facts on outer carton for Warnings. Remove contact lenses before using. To avoid contamination, do not touch tip of
`container to any surface.
`
`To open: push cap down while turning. Replace cap after each use.
`
`Keep this and all drugs out of reach of children.
`
`TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or
`missing at time of purchase.
`
`Store at 20° - 25°C (68° - 77°F).
`Protect from light.
`
`ALCON LABORATORIES, INC.
`FORT WORTH, TX 76134 USA
`
`LOT/EXP.:
`
`H15558-0419
`
`EYE ALLERGY RELIEF
`
`NAPHCON A®
`
`Naphazoline Hydrochloride 0.025%
`and Pheniramine Maleate 0.3%
`
`Ophthalmic Solution
`
`Redness Reliever and Antihistamine
`
`RELIEVES ITCHING & REDNESS
`
`EYE DROPS
`
`5/11
`
`Eye Therapies Exhibit 2192, 5 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Drug Facts
`
`CLINICALLY PROVEN
`
`STERILE 15 mL (0.5 FL OZ)
`
`Alcon®
`
`Active ingredients: Naphazoline
`Hydrochloride 0.025%,
`Pheniramine Maleate 0.3%.
`
`Uses: For the temporary relief of
`redness and itching of the eye(s)
`due to ragweed, pollen, grass,
`animal dander and hair.
`
`DIRECTIONS: Put 1 or 2 drops in
`the affected eye(s) up to 4 times
`daily. Children under 6 years:
`ask a doctor.
`
`WARNINGS: See Drug Facts on
`outer carton for Warnings. Remove
`contact lenses before using. To
`avoid contamination, do not touch
`tip of container to any surface.
`
`To open: push cap down while
`turning. Replace cap after each use.
`
`Keep this and all drugs out of reach
`of children.
`
`TAMPER EVIDENT: For your
`protection, this bottle has a seal
`imprinted with the word “Alcon”
`around the neck. Do not use if seal
`is damaged or missing at time of
`purchase. Store at 20° - 25°C
`(68° - 77°F). Protect from light.
`
`ALCON LABORATORIES, INC.
`FORT WORTH, TX 76134 USA
`
`LOT:
`
` EXP:
`
`300035727-0320
`
`6/11
`
`Eye Therapies Exhibit 2192, 6 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`PRINCIPAL DISPLAY PANEL
`
`Drug Facts
`
`Convenient • Take Anywhere
`
`EYE ALLERGY RELIEF
`
`POCKET SIZE
`
`NAPHCON A®
`
`Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%
`
`Ophthalmic Solution
`
`Redness Reliever and Antihistamine
`
`Relieves Itching & Redness
`
`EYE DROPS
`
`CLINICALLY PROVEN
`
`STERILE Two 5 mL (0.17 FL OZ) Bottles
`
`TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or
`missing at time of purchase.
`
`ACTUAL SIZE
`
`Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.
`
`ACTUAL FILL
`
`ALCON LABORATORIES, INC.
`6201 South Freeway
`Fort Worth, TX 76134
`
`ALCON
`LOT:
`EXP.:
`
`9017143-0419
`
`7/11
`
`Eye Therapies Exhibit 2192, 7 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Drug Facts
`
`EYE ALLERGY RELIEF
`
`NAPHCON A®
`
`Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%
`
`Ophthalmic Solution
`
`Redness Reliever and Antihistamine
`
`RELIEVES ITCHING & REDNESS
`
`EYE DROPS
`
`CLINICALLY PROVEN
`
`STERILE 5mL (0.17 FL OZ )
`
`Active ingredients: Naphazoline Hydrochloride 0.025%, Pheniramine Maleate 0.3%.
`
`Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.
`
`DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: ask a doctor.
`
`WARNINGS: See Drug Facts on outer carton for Warnings. Remove contact lenses before using. To avoid contamination, do not touch tip of
`container to any surface. To open: push cap down while turning. Replace cap after each use. Keep this and all drugs out of reach of children.
`
`TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or
`missing at time of purchase.
`
`8/11
`
`Eye Therapies Exhibit 2192, 8 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Drug Facts
`
`Store at 20° - 25°C (68° - 77°F).
`
`Protect from light.
`
`ALCON LABORATORIES, INC.
`FORT WORTH, TX 76134 USA
`
`LOT
`EXP:
`
`H15557-0419
`
`PRINCIPAL DISPLAY PANEL
`
`CONVENIENT • TAKE ANYWHERE
`
`EYE ALLERGY RELIEF
`
`POCKET SIZE
`
`NAPHCON A®
`
`Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%
`
`Ophthalmic Solution
`
`Redness Reliever and Antihistamine
`
`RELIEVES ITCHING & REDNESS
`
`EYE DROPS
`
`CLINICALLY PROVEN
`
`STERILE 5 mL (0.17 FL OZ)
`
`TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or
`missing at time of purchase.
`
`ACTUAL SIZE
`
`Combines a redness reliever and an antihistamine for temporary relief of itchy, red eyes.
`
`ACTUAL FILL
`
`ALCON LABORATORIES, INC.
`6201 South Freeway
`Fort Worth, TX 76134
`
`Alcon
`
`LOT:
`
`9/11
`
`Eye Therapies Exhibit 2192, 9 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`EXP.:
`
`9017128-0419
`
`Drug Facts
`
`NAPHCON A
`naphazoline hydrochloride and pheniramine maleate solution/ drops
`Product Information
`Product Type
`Route of Administration
`Active Ingredient/Active Moiety
`
`HUMAN OTC DRUG
`OPHTHALMIC
`
`Item Code (Source)
`
`NDC:0065-0085
`
`Ingredient Name
`Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV)
`Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M)
`Inactive Ingredients
`
`Basis of Strength
`Naphazoline Hydrochloride
`Pheniramine Maleate
`
`Strength
`0.25 mg in 1 mL
`3 mg in 1 mL
`
`Ingredient Name
`
`Strength
`
`Benzalkonium Chloride (UNII: F5UM2KM3W7)
`Boric Acid (UNII: R57ZHV85D4)
`Edetate Disodium (UNII: 7FLD91C86K)
`Water (UNII: 059QF0KO0R)
`
`10/11
`
`Eye Therapies Exhibit 2192, 10 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Drug Facts
`
`Sodium Borate (UNII: 91MBZ8H3QO)
`Sodium Chloride (UNII: 451W47IQ8X)
`Sodium Hydroxide (UNII: 55X04QC32I)
`Hydrochloric Acid (UNII: QTT17582CB)
`
`Packaging
`#
`Item Code
`1 NDC:0065-0085-15
`1
`2 NDC:0065-0085-38
`2
`3 NDC:0065-0085-42
`3
`4 NDC:0065-0085-52
`4
`
`Package Description
`
`1 in 1 CARTON
`15 mL in 1 BOTTLE; Type 0: Not a Combination Product
`1 in 1 CARTON
`30 mL in 1 BOTTLE; Type 0: Not a Combination Product
`2 in 1 CARTON
`5 mL in 1 BOTTLE; Type 0: Not a Combination Product
`1 in 1 CARTON
`5 mL in 1 BOTTLE; Type 0: Not a Combination Product
`
`Marketing Information
`Application Number or Monograph Citation
`Marketing Category
`NDA020226
`NDA
`Labeler - Alcon Laboratories, Inc. (008018525)
`Registrant - Alcon Laboratories, Inc. (008018525)
`Establishment
`
`Marketing Start Date Marketing End Date
`06/08/1994
`
`06/08/1994
`
`06/08/1994
`
`06/08/1994
`
`02/28/2019
`
`11/01/2023
`
`11/30/2021
`
`Marketing Start Date
`06/08/1994
`
`Marketing End Date
`
`Name
`Alcon Research LLC
`
`Address
`
`ID/FEI
`007672236
`
`Business Operations
`manufacture(0065-0085)
`
`Revised: 6/2022
`Document Id: fe43207e-46ec-4284-b54f-c279edba278b
`Set id: 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58
`Version: 13
`Effective Time: 20220622
`
`Alcon Laboratories, Inc.
`
`11/11
`
`Eye Therapies Exhibit 2192, 11 of 11
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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