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: Redpharm Drug
Product type: HUMAN OTC DRUG
SPL set ID: 52c62397-58f1-d34d-e063-6294a90a6faf
SPL ID: 52c62238-e1be-981f-e063-6394a90aaa8d
Version: 1
Effective date: 2026-05-27
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:06:37

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		Redpharm Drug	openfda.manufacturer_name
ndc	package	67296-2245-5	openfda.package_ndc
ndc	product	67296-2245	openfda.product_ndc
ndc11	package	67296224505	derived:openfda.package_ndc
rxcui		311237	openfda.rxcui
spl id		52c62238-e1be-981f-e063-6394a90aaa8d	id
spl set id		52c62397-58f1-d34d-e063-6294a90a6faf	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.