FDA.reportPublic FDA data

Topcare Maximum Redness Relief Eye Drops

Manufacturer
Topco Assoc LLC | 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 Maximum Redness Relief Eye Drops
Active ingredientGLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Glycerin.....0.5%

Naphazoline hydrochloride....0.03%

OTC - PURPOSE SECTION

Purpose

Glycerin..................................Lubricant

Naphazoline hydrochloride.....Redness reliever

INDICATIONS & USAGE SECTION

Uses

  • For the relief of redness of the eye due to minor eye irritations
  • For the temporary relief of burning and irritation due to dryness of the eye
  • For use as a protectant against further irritation or dryness of the eye

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When using this product

  • To avoid contamination, do not touch tip of container to any surface
  • Replace cap after using
  • Overuse may produce increased redness of the eye
  • Pupils may become enlarged temporarily

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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

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

OTHER SAFETY INFORMATION

Other information

  • store at room temperature
  • remove contact lenses before using
  • Tamper evident: Do not use this product if imprinted neckband is missing or broken

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN3
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD3
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-975-01Topcare Maximum Redness Relief Eye Drops1 in 1 CARTONSOLUTION13
36800-975-01Topcare Maximum Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-975TOPCARE MAXIMUM REDNESS RELIEF EYE DROPS (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION [TOPCO ASSOC LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c6193a6-d824-1b27-e053-2995a90ab3cf.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
36800-97536800-975-01

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
GLYCERINPDC6A3C0OXACTIB
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT

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
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
ndc (package): 36800-975-01
ndc (product): 36800-975
ndc11 (package): 36800097501
spl id: 0cfa9846-2cd8-d0fc-e063-6394a90af06b
spl set id: 9c6193a6-d824-1b27-e053-2995a90ab3cf

Reported adverse events (FAERS/openFDA)#

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