FDA.reportPublic FDA data

Kroger Eye Drops Seasonal Relief

Manufacturer
Kroger | KC Pharmaceuticals, Inc. | K.C. Pharmaceuticals, Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:20

Label at a glance#

ProductKroger Eye Drops Seasonal Relief
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Tetrahydrozoline HCl....0.05%

Zinc sulfate.....0.25%

OTC - PURPOSE SECTION

Purposes

Tetrahydrozoline HCl......Redness reliever

Zinc sulfate......Astringent

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

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

OTHER SAFETY INFORMATION

Other information

store at 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN2
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD2
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY2
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY2

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-349-01Kroger Eye Drops Seasonal Relief1 in 1 CARTONSOLUTION12
30142-349-01Kroger Eye Drops Seasonal Relief15 mL in 1 BOTTLE, DROPPERSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-349KROGER EYE DROPS SEASONAL RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [KROGER]2Current NDC, 2 package rows20231221_f6829be4-e3b7-7ff2-e053-2995a90a80fc.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
30142-34930142-349-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC SULFATE89DS0H96TBACTIM
BORIC ACIDR57ZHV85D4IACT

Source Document#

Source XML

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Eye Drops Seasonal ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEKrogerf6829be4-e3b7-7ff2-e053-2995a90a80fc2023-12-20WarningsExact identifier
ndc (package): 30142-349-01
ndc (product): 30142-349
ndc11 (package): 30142034901
spl id: 0cfa1586-42f8-ba69-e063-6394a90ab310
spl set id: f6829be4-e3b7-7ff2-e053-2995a90a80fc