PUR-WASH

Manufacturer
Niagara Pharmaceuticals Inc. | STERIS Applied Sterilization Technologies ULC | Isomedix Operations Inc.
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:17:50

Label at a glance#

ProductPUR-WASH
Active ingredientWATER
Label structure11 sections

Dosage and administration

• pull cover off cap • avoid contamination of rim and inside surfaces of the eyecup • place eyecup surface to the affected eye, pressing tightly to prevent the escape of the liquid and tilt the head backward • 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water 98.3%

Purpose

OTC - PURPOSE SECTION

Eyewash

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifyou have any of the following

  • 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

DOSAGE & ADMINISTRATION SECTION

• pull cover off cap

• avoid contamination of rim and inside surfaces of the eyecup

• place eyecup surface to the affected eye, pressing tightly to prevent the escape of the liquid and tilt the head backward

• 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

SPL UNCLASSIFIED SECTION

  • lot number is printed on the bottle
  • store at 20° to 25° C [68° to 77° F]
  • do not use if tamper evident ring is 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

SPL UNCLASSIFIED SECTION

Manufactured by:
Niagara Pharmaceuticals Inc.
60 Innovation Dr.
Flamborough ON L9H 7P3

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts LabelDrug Facts Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1424605Pur-Wash 98.3 % Ophthalmic Irrigation SolutionPSN6
1151101water 98.3 % Ophthalmic Irrigation SolutionPSN6
1424605water 983 MG/ML Ophthalmic Irrigation Solution [Pur-Wash]SBD6
1151101water 983 MG/ML Ophthalmic Irrigation SolutionSCD6
1424605Pur-Wash 98.3 % Ophthalmic Irrigation SolutionSY6
1424605Pur-Wash 983 MG/ML Ophthalmic Irrigation SolutionSY6
1151101water 98.3 % Ophthalmic Irrigation SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65785-166-01PUR-WASH473 mL in 1 BOTTLE, UNIT-DOSESOLUTION4736
65785-166-02PUR-WASH946 mL in 1 BOTTLE, UNIT-DOSESOLUTION9466

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WaterACTIVE INGREDIENT059QF0KO0R1
WaterACTIVE MOIETY059QF0KO0R1
Boric AcidINACTIVE INGREDIENTR57ZHV85D41
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QO1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1

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
65785-16665785-166-01, 65785-166-02

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

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 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSOLUTION / OPHTHALMIC2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSOLUTION / OPHTHALMIC2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSOLUTION / OPHTHALMIC2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01c2088c7a36db…
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…

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
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
ndc (package): 65785-166-01
ndc (package): 65785-166-02
ndc (product): 65785-166
ndc11 (package): 65785016601
ndc11 (package): 65785016602
spl id: 445cda76-0258-6e3c-e063-6294a90a5154
spl set id: 7289103a-5cbf-42f4-8848-e827149a43ca

Reported adverse events (FAERS/openFDA)#

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