FDA.reportPublic FDA data

Medics Choice Eye Drops Seasonal Relief

Manufacturer
KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:30:25

Label at a glance#

ProductMedics Choice Eye Drops Seasonal Relief
Active ingredientZINC SULFATE, TETRAHYDROZOLINE HYDROCHLORIDE
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 irritations

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

(1-800-222-1222) 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 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN6
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD6
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY6
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130095072024511GTIN-13: 0095072024511
EAN-13: 0095072024511
GTIN-12: 095072024511
UPC-A: 095072024511
GTIN storage (14 digits): 00095072024511		MCSeasonalRelAC.jpg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55651-024-01Medics Choice Eye Drops Seasonal Relief1 in 1 CARTONSOLUTION/ DROPS16
55651-024-01Medics Choice Eye Drops Seasonal Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS156

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7D1
ZINC SULFATEACTIVE INGREDIENT89DS0H96TB1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y0771
ZINCACTIVE MOIETYJ41CSQ7QDS1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D41
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
55651-02455651-024-01

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
ZINC SULFATE89DS0H96TBACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Medics Choice Eye Drops Seasonal ReliefTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEKC Pharmaceuticals, Inc.92bd8cb4-90ad-4a47-afa4-30d1fa658d622025-12-30WarningsExact identifier
ndc (package): 55651-024-01
ndc (product): 55651-024
ndc11 (package): 55651002401
spl id: 4748cbbd-a95a-77cf-e063-6294a90a92b5
spl set id: 92bd8cb4-90ad-4a47-afa4-30d1fa658d62

Reported adverse events (FAERS/openFDA)#

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