FDA.reportPublic FDA data

Quality Choice Eye Drops Irritation Relief

Manufacturer
Quality Choice | K.C. Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:52

Label at a glance#

ProductQuality Choice Eye Drops Irritation Relief
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCl 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 irritation

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 lenses before using

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

Other information

OTHER SAFETY INFORMATION

store at 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Quality Choice Eye Drops Irritation Relief 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice Eye Drops Irritation Relief 15mLQuality Choice Eye Drops Irritation Relief 15mL

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130635515995055GTIN-13: 0635515995055
EAN-13: 0635515995055
GTIN-12: 635515995055
UPC-A: 635515995055
GTIN storage (14 digits): 00635515995055		Quality Choice Irritation Relief Eye Drops (New NDC).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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-190-14Quality Choice Eye Drops Irritation Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
83324-190-14Quality Choice Eye Drops Irritation Relief1 in 1 BOXSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-190-14ML - Milliliter83324-19094af6ec9-f2aa-4877-990d-9329f2d25e4012025-05-14

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
83324-19083324-190-14

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

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
Quality Choice Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEQuality Choice1f682079-6e91-e14b-e063-6394a90a3f122025-12-30WarningsExact identifier
ndc (package): 83324-190-14
ndc (product): 83324-190
ndc11 (package): 83324019014
spl id: 4749597d-57d7-92b6-e063-6294a90ab574
spl set id: 1f682079-6e91-e14b-e063-6394a90a3f12

Reported adverse events (FAERS/openFDA)#

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