Goniovisc

Manufacturer
HUB Pharmaceuticals, LLC | Contacare Ophthalmics & Diagnostics
Effective date
2017-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:53:42

Label at a glance#

ProductGoniovisc Ophthalmic Lubricant
Active ingredientHYPROMELLOSE 2910 (4000 MPA.S)
Label structure11 sections

Indications and uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye. For use in the eyes only.

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Storage and handling

Store at room temperature 15°-30°C (59°-86°F). Do not freeze. Keep box for complete information.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients             Purpose

Hypromellose 25 mg (2.5%)......Lubricant

USES:

OTC - PURPOSE SECTION

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
  • For use in the eyes only.

Indications & Usage:

INDICATIONS & USAGE SECTION

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

WARNINGS:

WARNINGS SECTION

  • For external use only.
  • Do not use if sealed bottle tip is broken or punctured.
  • If solution changes color or becomes cloudy, do not use.

When using this product

OTC - WHEN USING SECTION

  • To avoid contamination, do not touch tip of container to any surface.

  • Replace cap after using.

Stop use and ask a physician

OTC - STOP USE SECTION

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, discontinue use and consult a doctor.

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

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER INFORMATION:

STORAGE AND HANDLING SECTION

  • Store at room temperature 15°-30°C (59°-86°F).
  • Do not freeze.
  • Keep box for complete information.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

  • Boric Acid
  • Edetate Disodium
  • Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0-7.8)
  • Sodium Borate

  • Water for Injection

Preservative:

  • Benzalkonium Chloride Solution NF 0.02% v/v

Questions?

OTC - QUESTIONS SECTION

1-800-Eye-Drop (393-3767)

PACKAGE LABELS:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Goniovisc Bottle LabelGoniovisc Bottle Label



Image 1: Label for Bottle

Goniovisc Box LabelGoniovisc Box Label

Image 2: Label for Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998019GONIOVISC 2.5 % Ophthalmic SolutionPSN5
310934hypromellose 2.5 % Ophthalmic SolutionPSN5
998019hypromellose 25 MG/ML Ophthalmic Solution [Goniovisc]SBD5
310934hypromellose 25 MG/ML Ophthalmic SolutionSCD5
998019Goniovisc 2.5 % Ophthalmic SolutionSY5
998019Goniovisc 25 MG/ML Ophthalmic SolutionSY5
310934hypromellose 2.5 % Ophthalmic SolutionSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130317238610155GTIN-13: 0317238610155
EAN-13: 0317238610155
GTIN-12: 317238610155
UPC-A: 317238610155
GTIN storage (14 digits): 00317238610155
Goniovisc Box Label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17238-610-152020-01-31C16284748780-19d75b9d0-17d1-f424-e053-dadaa90a57ceGONIOVISC Eye Lubricant Hypromellose Ophthalmic Solution, USP 2.5%, Drops (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17238-610-15GonioviscOphthalmic Lubricant15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155
17238-610-15GonioviscOphthalmic Lubricant1 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17238-610GONIOVISC OPHTHALMIC LUBRICANT (HYPROMELLOSE 2910 (4000 MPA.S)) SOLUTION/ DROPS [HUB PHARMACEUTICALS, LLC]5Legacy NDC, 2 package rows20171226_b8b57c41-aae6-4cbd-8fbf-0a1c6fa196d9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17238-610-15ML - Milliliter17238-610b1e6329f-3162-4c78-9fd0-7fc3c3225b0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYPROMELLOSE 2910 (4000 MPA.S)ACTIVE INGREDIENTRN3152OP352
HYPROMELLOSE 2910 (4000 MPA.S)ACTIVE MOIETYRN3152OP352
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W72
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D42
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17238-61017238-610-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 446 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADISCALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, EMULSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / DENTALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBTABLET / ORAL2.32 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / NASAL91.7 mg/100mlExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBTABLET, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
148 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4MOUTHWASH / BUCCAL7.36 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / PERIODONTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS5 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVESICAL157 mgExact identifier — unii candidate
148 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / DENTALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBOINTMENT / TOPICALNAExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / RESPIRATORY (INHALATION)8 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates

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
6140e883-8107-44f3-e053-2991aa0a1ba1b8b57c41-aae6-4cbd-8fbf-0a1c6fa196d92017-12-26WarningsExact identifier
spl id: 6140e883-8107-44f3-e053-2991aa0a1ba1
spl set id: b8b57c41-aae6-4cbd-8fbf-0a1c6fa196d9

Reported adverse events (FAERS/openFDA)#

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