FDA.reportPublic FDA data

GNP Eye Drops Seasonal Relief

Manufacturer
AmerisourceBergen | KC Pharmaceuticals, Inc. | 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 Eye Drops Seasonal Relief
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE
Label structure9 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 irritation

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 (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 chloride, sodium citrate

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-888-527-4276

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

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
46122-602-05GNP Eye Drops Seasonal Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153
46122-602-05GNP Eye Drops Seasonal Relief1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-602GNP EYE DROPS SEASONAL RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [AMERISOURCEBERGEN]3Legacy NDC, 2 package rows20231224_9b11b129-7787-8a9d-e053-2995a90a45fe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-602-05ML - Milliliter46122-602bc344282-903d-47f4-8972-4a1a6b03f94a12023-02-06

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
46122-60246122-602-05

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

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
5353357b-bbcb-5db2-e063-6394a90a56419b11b129-7787-8a9d-e053-2995a90a45fe2026-06-03WarningsExact identifier
spl set id: 9b11b129-7787-8a9d-e053-2995a90a45fe

Reported adverse events (FAERS/openFDA)#

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