FDA.reportPublic FDA data

Meijer Seasonal Itching and Redness Relief

Manufacturer
Meijer Distribution, Inc. | KC Pharmaceuticals, Inc.
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:30

Label at a glance#

ProductMeijer Seasonal Itching and Redness Relief
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE
Label structure9 sections

Dosage and administration

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCI 0.05%

Zinc sulfate 0.25%

Purposes

OTC - PURPOSE SECTION

Redness reliever

Astringent

Use

INDICATIONS & USAGE SECTION

  • for temporary relief of discomfort and redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Other information

OTHER SAFETY INFORMATION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-527-4276

Meijer Seasonal Itching & Redness Relief 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meijer Seasonal Itching & Redness Relief 15mLMeijer Seasonal Itching & Redness Relief 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN3
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD3
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY3
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-598-01Meijer Seasonal Itching and Redness Relief1 in 1 BOXSOLUTION/ DROPS13
41250-598-01Meijer Seasonal Itching and Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-598MEIJER SEASONAL ITCHING AND REDNESS RELIEF (TETRAHYDROZOLINE HCI, ZINC SULFATE) SOLUTION/ DROPS [MEIJER DISTRIBUTION, INC.]3Current NDC, Legacy NDC, 2 package rows20231223_9fead2de-2fe6-4dab-e053-2995a90a2742.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-59841250-598-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
BORIC ACIDR57ZHV85D4IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
ZINC SULFATE89DS0H96TBACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Seasonal Itching and Redness ReliefTETRAHYDROZOLINE HCI, ZINC SULFATEMeijer Distribution, Inc.9fead2de-2fe6-4dab-e053-2995a90a27422023-12-22WarningsExact identifier
ndc (package): 41250-598-01
ndc (product): 41250-598
ndc11 (package): 41250059801
spl id: 0d22c2c2-a705-2509-e063-6294a90ae206
spl set id: 9fead2de-2fe6-4dab-e053-2995a90a2742

Reported adverse events (FAERS/openFDA)#

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