Itchy Eye

Manufacturer
Meijer Distribution Inc | Akorn Operating Company LLC | Akorn | Akorn AG
Effective date
2022-02-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:48:12

Label at a glance#

ProductItchy Eye
Active ingredientketotifen fumarate
Label structure11 sections

Dosage and administration

Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor If you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
  • Children under 3 years of age: Consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • only for use in the eye.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-932-5676

Serious side effects associated with use of this product may be reported to this number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 41250-303-01

Meijer™ Logo

Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution 0.035%

Antihistamine

Eye Drops

10 mL

0.34 FL OZ

STERILE

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 41250-303-01 Compare to Alaway®

active ingredient*

Meijer™ Logo

UP TO 12

HOURS OF RELIEF

Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Works in Minutes

Original Prescription Strength

For ages 3 years and older

60-day supply

10 mL 0.34 FL OZ STERILE

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN5
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD5
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY5
311237ketotifen 0.025 % Ophthalmic SolutionSY5
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOTIFEN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-303-012024-01-30C16284748780-11030e365-3f1a-111a-e063-dadaa90a10e211c16152-6feb-45c9-99e3-af514caa2681

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-303-01Itchy Eye1 in 1 CARTONSOLUTION/ DROPS15
41250-303-01Itchy Eye10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-303ITCHY EYE (KETOTIFEN FUMARATE) SOLUTION/ DROPS [MEIJER DISTRIBUTION INC]5Legacy NDC, 2 package rows20220212_11c16152-6feb-45c9-99e3-af514caa2681.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-30341250-303-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077958-001KETOTIFEN FUMARATEKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2684e616aacf4f…
2026-08-18 06:07:402026-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
095bec2c-97d8-45a3-be5f-e3601c017a6f11c16152-6feb-45c9-99e3-af514caa26812022-02-11WarningsExact identifier
spl id: 095bec2c-97d8-45a3-be5f-e3601c017a6f
spl set id: 11c16152-6feb-45c9-99e3-af514caa2681

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.