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: Walgreen Company
Product type: HUMAN OTC DRUG
SPL set ID: 9ce8f926-c202-40d1-9dba-0477f1f49e14
SPL ID: 4ddfb3f8-812d-c7c4-e063-6394a90a284d
Version: 9
Effective date: 2026-03-25
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:35:47

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		Walgreen Company	openfda.manufacturer_name
ndc	package	0363-0038-10	openfda.package_ndc
ndc	package	0363-0038-05	openfda.package_ndc
ndc	product	0363-0038	openfda.product_ndc
ndc11	package	00363003810	derived:openfda.package_ndc
ndc11	package	00363003805	derived:openfda.package_ndc
rxcui		311237	openfda.rxcui
spl id		4ddfb3f8-812d-c7c4-e063-6394a90a284d	id
spl set id		9ce8f926-c202-40d1-9dba-0477f1f49e14	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 content 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.