Equate Eye Itch Relief

Manufacturer
Wal-Mart Stores, Inc. | Bausch & Lomb Incorporated
Effective date
2021-03-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:30

Label at a glance#

ProductEquate Eye Itch Relief
Active ingredientKETOTIFEN FUMARATE
Label structure8 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 or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. 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
  • 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:
  • 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 3 years or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-231-11

equate™

Eye Itch
Relief
ketotifen fumarate

ophthalmic
solution 0.035%

ANTIHISTAMINE
EYE DROPS

  • Works in minutes
  • Original prescription strength
  • For ages 3 years and older
  • STERILE

UP TO 12 HOURS

2 x 10 mL BOTTLES
(0.34 FL OZ EACH)

carton
carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN3
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD3
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY3
311237ketotifen 0.025 % Ophthalmic SolutionSY3
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY3

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
49035-231-10Equate Eye Itch Relief1 in 1 CARTONSOLUTION13
49035-231-10Equate Eye Itch Relief10 mL in 1 BOTTLESOLUTION103
49035-231-11Equate Eye Itch Relief10 mL in 1 BOTTLESOLUTION103
49035-231-11Equate Eye Itch Relief2 in 1 CARTONSOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-231EQUATE EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [WAL-MART STORES, INC.]3Current NDC, Legacy NDC, 4 package rows20210408_accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-231-10ML - Milliliter49035-23153508346-77a0-4fcb-b4b6-260c5be00e8712023-03-13

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
49035-23149035-231-10, 49035-231-11

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
Equate Eye Itch ReliefKETOTIFEN FUMARATEWal-Mart Stores, Inc.accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb92021-03-23WarningsExact identifier
ndc (package): 49035-231-11
ndc (package): 49035-231-10
ndc (product): 49035-231
ndc11 (package): 49035023110
ndc11 (package): 49035023111
spl id: 23a94887-f625-4a01-bcda-131ca5286372
spl set id: accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9

Reported adverse events (FAERS/openFDA)#

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