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: Eye Itch Relief
Generic name: KETOTIFEN FUMARATE
Manufacturer: Cardinal Health
Product type: HUMAN OTC DRUG
SPL set ID: e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8
SPL ID: 5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623
Version: 3
Effective date: 2023-12-08
Source export date: 2026-10-30
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/8d15bdc5962e7531569eaeb5b1b2e4919574d40a6782ab67345a27b890175a00/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:55:30

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		Eye Itch Relief	openfda.brand_name
generic name		KETOTIFEN FUMARATE	openfda.generic_name
manufacturer name		Cardinal Health	openfda.manufacturer_name
ndc	package	70000-0522-2	openfda.package_ndc
ndc	package	70000-0522-1	openfda.package_ndc
ndc	product	70000-0522	openfda.product_ndc
ndc11	package	70000052202	derived:openfda.package_ndc
ndc11	package	70000052201	derived:openfda.package_ndc
rxcui		311237	openfda.rxcui
spl id		5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623	id
spl set id		e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8	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.