Equate Eye Itch Relief

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Equate Eye Itch Relief
Generic name: KETOTIFEN FUMARATE
Manufacturer: Wal-Mart Stores, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9
SPL ID: 23a94887-f625-4a01-bcda-131ca5286372
Version: 3
Effective date: 2021-03-23
Source export date: 2026-11-06
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:31:29

Harmonized routes table
Harmonized routes
OPHTHALMIC

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	021996	derived:openfda.application_number
application number		NDA021996	openfda.application_number
brand name		Equate Eye Itch Relief	openfda.brand_name
generic name		KETOTIFEN FUMARATE	openfda.generic_name
manufacturer name		Wal-Mart Stores, Inc.	openfda.manufacturer_name
ndc	package	49035-231-11	openfda.package_ndc
ndc	package	49035-231-10	openfda.package_ndc
ndc	product	49035-231	openfda.product_ndc
ndc11	package	49035023110	derived:openfda.package_ndc
ndc11	package	49035023111	derived:openfda.package_ndc
rxcui		311237	openfda.rxcui
spl id		23a94887-f625-4a01-bcda-131ca5286372	id
spl set id		accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9	set_id
unii		HBD503WORO	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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

Reported adverse events (FAERS/openFDA)#

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