Eye Itch Relief

Manufacturer
Kroger Company | Bausch & Lomb Incorporated
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:31

Label at a glance#

ProductEye Itch Relief
Active ingredientKETOTIFEN FUMARATE
Label structure7 sections

Indications and uses

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Dosage and administration

• adults and children 3 years and older: • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • children under 3 years of age: consult a doctor store at 4-25 °C (39-77 °F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

WARNINGS SECTION

For external use only

Do not use

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

When using this product

SPL UNCLASSIFIED SECTION

  • remove contact lenses before use
  • wait at least 10 minutes before re-inserting contact lenses after use
  • 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 experience any of the following:

SPL UNCLASSIFIED SECTION

  • eye pain
  • changes in vision
  • redness of the eyes
  • itching that worsens or lasts for 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 and older:
    • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
    • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • children under 3 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

store at 4-25 °C (39-77 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions or comments?

OTC - QUESTIONS SECTION

[phone icon]Call: 1-800-632-6900

DISTRIBUTED BY:
THE KROGER CO., CINCINNATI, OHIO 45202
PRODUCT OF ITALY

*Systane® and Zaditor® are registered
trademarks of Alcon, Inc., Fribourg,
Switzerland CH-1701. Alcon, Inc. is not
affiliated with The Kroger Co. or this product.

QUALITY GUARANTEE
1-800-632-6900
www.kroger.com

9767401

MK60107

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton 5ml
carton 5ml

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-398-05Eye Itch Relief5 mL in 1 BOTTLESOLUTION/ DROPS55
30142-398-05Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-398EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20231215_eb81286f-72b4-42b3-a596-439d0aeae93f.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
30142-39830142-398-05

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021996-001ALAWAYKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01
N021996-002CHILDREN'S ALAWAYKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0184e616aacf4f…
2026-09-14 22:38:342026-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1184e616aacf4f…
2026-08-18 06:07:402026-07N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1174a2ff9319b5…

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
Eye Itch ReliefKETOTIFEN FUMARATEKroger Companyeb81286f-72b4-42b3-a596-439d0aeae93f2023-12-08WarningsExact identifier
ndc (package): 30142-398-05
ndc (product): 30142-398
ndc11 (package): 30142039805
spl id: c9bce135-e1e4-4faa-b74c-22f69a060a3e
spl set id: eb81286f-72b4-42b3-a596-439d0aeae93f

Reported adverse events (FAERS/openFDA)#

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