FDA.reportPublic FDA data

TopCare Health Original Eye Drops

Manufacturer
Topco Associates LLC | K.C. Pharmaceuticals, Inc | K.C. Pharmaceuticals, Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:12

Label at a glance#

ProductTopCare Health Original Eye Drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acive ingredient

Tetrahydrozoline HCl.....0.05%

OTC - PURPOSE SECTION

Purpose

Tetrahydrozoline HCl........Redness reliever

INDICATIONS & USAGE SECTION

Use

  • relieves 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 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN3
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD3
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY3
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY3

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
36800-858-01TopCare Health Original Eye Drops1 in 1 CARTONSOLUTION13
36800-858-01TopCare Health Original Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-858TOPCARE HEALTH ORIGINAL EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c61a56a-c1a9-2846-e053-2995a90a755b.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-85836800-858-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB

Source Document#

Source XML · Source PDF

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
TopCare Health Original Eye DropsTETRAHYDROZOLINE HCLTopco Associates LLC9c61a56a-c1a9-2846-e053-2995a90a755b2023-12-20WarningsExact identifier
ndc (package): 36800-858-01
ndc (product): 36800-858
ndc11 (package): 36800085801
spl id: 0cfa5c76-fce8-9f22-e063-6394a90ade89
spl set id: 9c61a56a-c1a9-2846-e053-2995a90a755b

Reported adverse events (FAERS/openFDA)#

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