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: Safeway
Product type: HUMAN OTC DRUG
SPL set ID: 5fccbb63-7859-484c-b7b3-9de711364c09
SPL ID: 38519d56-77cc-43cc-9b74-6ef2fc796a0d
Version: 5
Effective date: 2024-05-16
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:03:52

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 · 12 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		Safeway	openfda.manufacturer_name
ndc	package	21130-601-05	openfda.package_ndc
ndc	product	21130-601	openfda.product_ndc
ndc11	package	21130060105	derived:openfda.package_ndc
rxcui		311237	openfda.rxcui
spl id		38519d56-77cc-43cc-9b74-6ef2fc796a0d	id
spl set id		5fccbb63-7859-484c-b7b3-9de711364c09	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

Reported adverse events (FAERS/openFDA)#

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