Eyewash

Manufacturer
Global Equipment Company | Niagara Pharmaceuticals, Inc.
Effective date
2021-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:54

Label at a glance#

ProductEyewash
Active ingredientWATER
Label structure13 sections

Dosage and administration

remove tamper evident seal and cap avoid contamination of rim and inside surfaces of the nozzle place nozzle to the affected area and tilt the bottle to pour liquid out through the nozzle open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water 98.3%

Purpose

OTC - PURPOSE SECTION

Eyewash

Warnings

WARNINGS AND PRECAUTIONS SECTION

For external use only

Do not use

  • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
  • if solution changes color or becomes cloudy

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard

Use

INDICATIONS & USAGE SECTION

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Stop use and ask a doctor if you have any of the following

OTC - ASK DOCTOR SECTION

  • continued redness or irritation of the eye
  • condition worsens or persists
  • eye pain
  • changes in vision

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • remove tamper evident seal and cap
  • avoid contamination of rim and inside surfaces of the nozzle
  • place nozzle to the affected area and tilt the bottle to pour liquid out through the nozzle
  • open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Other information

INFORMATION FOR PATIENTS SECTION

  • lot number is printed on the bottle
  • store at 20° to 25° C [68° to 77° F]
  • for your protection, this bottle has an imprinted white seal with black printing “TAMPER EVIDENT SEAL”
  • do not use if this seal is missing or broken
  • use before expiration date marked on bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, sodium borate, sodium chloride

Questions?

OTC - QUESTIONS SECTION

☎ Call 905-690-6277 9 a.m. to 5 p.m. EST Mon-Fri

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

  • remove tamper evident seal and cap
  • avoid contamination of rim and inside surfaces of the nozzle
  • place nozzle to the affected area and tilt the bottle to pour liquid out through the nozzle
  • open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Warnings

WARNINGS SECTION

For external use only

Package Label.Principal Display Panel

PDP-Drug FactsPDP-Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1151101water 98.3 % Ophthalmic Irrigation SolutionPSN1
1151101water 983 MG/ML Ophthalmic Irrigation SolutionSCD1
1151101water 98.3 % Ophthalmic Irrigation SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78641-786-67Eyewash473 mL in 1 BOTTLE, UNIT-DOSESOLUTION4731
78641-786-68Eyewash946 mL in 1 BOTTLE, UNIT-DOSESOLUTION9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78641-786EYEWASH SOLUTION [GLOBAL EQUIPMENT COMPANY]1Current NDC, Legacy NDC, 2 package rows20210619_c4f78121-4668-2e0c-e053-2995a90ab6c6.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78641-78678641-786-67, 78641-786-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022305-001PUR-WASHPURIFIED WATER98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0184e616aacf4f…
2026-08-18 06:07:402026-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013f01610625f2…
2019-09-15 20:21 UTC2019-09N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01b00525d2431f…
2019-07-19 19:46 UTC2019-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01f41ea6bd6efb…

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
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
ndc (package): 78641-786-67
ndc (package): 78641-786-68
ndc (product): 78641-786
ndc11 (package): 78641078668
ndc11 (package): 78641078667
spl id: c4f783d3-b047-ab39-e053-2995a90ab6f3
spl set id: c4f78121-4668-2e0c-e053-2995a90ab6c6

Reported adverse events (FAERS/openFDA)#

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