FDA.reportPublic FDA data

GNP Eye Drops Maximum Redness Relief (PLD)

Manufacturer
AmerisourceBergen | K.C. Pharmaceuticals, Inc.
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:35

Label at a glance#

ProductGNP EyeDrops Maximum Redness Relief
Active ingredientNAPHAZOLINE HYDROCHLORIDE, GLYCERIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Glycerin.....0.5%

Naphazoline HCl...0.03%

OTC - PURPOSE SECTION

Purpose

Glycerin.....Lubricant

Naphazoline HCl...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 producte 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 (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 room temperature
  • remove contact lenses before using

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-866-627-4278

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

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
46122-603-05GNP EyeDrops Maximum Redness Relief1 in 1 CARTONSOLUTION13
46122-603-05GNP EyeDrops Maximum Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-603GNP EYEDROPS MAXIMUM REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HCL) SOLUTION [AMERISOURCEBERGEN]3Legacy NDC, 2 package rows20231224_9b594424-08ad-c006-e053-2a95a90af91e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-603-05ML - Milliliter46122-603f6ac5a55-6337-4e53-b8d3-bee1ad66244e12023-02-06

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
46122-60346122-603-05

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
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
GLYCERINPDC6A3C0OXACTIB
BORIC ACIDR57ZHV85D4IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BORATE91MBZ8H3QOIACT

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
53539606-c89e-cb5f-e063-6394a90a35a99b594424-08ad-c006-e053-2a95a90af91e2026-06-03WarningsExact identifier
spl set id: 9b594424-08ad-c006-e053-2a95a90af91e

Reported adverse events (FAERS/openFDA)#

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