Eye Itch Relief

Manufacturer
Safeway | Bausch & Lomb Incorporated
Effective date
2024-05-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:12:24

Label at a glance#

ProductEye Itch Relief
Active ingredientKETOTIFEN FUMARATE
Label structure11 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen 0.025%

Purpose

OTC - PURPOSE SECTION

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Uses

INDICATIONS & USAGE SECTION

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

WarningsFor external use only

WARNINGS SECTION

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

  • 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

OTC - STOP USE SECTION

you experience any of the following:

  • 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?

OTC - QUESTIONS SECTION

{Phone icon} Call: 1-800-459-7043

*This product is not manufactured or distributed by Alcon owner of the trademarks Systane and ZADITOR.

Package/Label Principal Display Panel – 5mL carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to

Systane ZADITOR

active ingredient*

NDC 21130-601-05

Signature
SELECT®

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS

Up to 12 hours

Works in minutes

Original prescription strength

For ages 3 years and older


STERILE 0.17 FL OZ (5 mL)

20074700

GI60107

carton
carton

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
21130-601-05Eye Itch Relief5 mL in 1 BOTTLESOLUTION55
21130-601-05Eye Itch Relief1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-601EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]5Current NDC, Legacy NDC, 2 package rows20240514_5fccbb63-7859-484c-b7b3-9de711364c09.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
KETOTIFEN FUMARATEACTIVE INGREDIENTHBD503WORO1
KETOTIFENACTIVE MOIETYX49220T18G1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
21130-60121130-601-05

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / OPHTHALMIC0.31 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / OPHTHALMIC0.31 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01c2088c7a36db…
2026-10-15 13:18:302026-09N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11c2088c7a36db…
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…

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 FUMARATESafeway5fccbb63-7859-484c-b7b3-9de711364c092024-05-16WarningsExact identifier
ndc (package): 21130-601-05
ndc (product): 21130-601
ndc11 (package): 21130060105
spl id: 38519d56-77cc-43cc-9b74-6ef2fc796a0d
spl set id: 5fccbb63-7859-484c-b7b3-9de711364c09

Reported adverse events (FAERS/openFDA)#

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