Pur-Wash Purified Water, 98.3% Ophthalmic Solution Eyewash

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 01:17:55

Label at a glance#

ProductPUR-WASH

Active ingredientWATER

Label structure11 sections

Dosage and administration

snap off ridged tamper-evident tip Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Storage and handling

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

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

PhoneLabel contact973-568-3361

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 if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088
changes in vision
eye pain
condition worsens or persists
continued redness or irritation of the eye

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

snap off ridged tamper-evident tip
Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other information

STORAGE AND HANDLING 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 973-568-3361 9 a.m. to 5 p.m. EST Mon-Fri

SPL UNCLASSIFIED SECTION

Manufactured by:

Niagara Pharmaceuticals Inc.

60 Innovation Dr.

Dundas ON L9H 7P3

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1424605	Pur-Wash 98.3 % Ophthalmic Irrigation Solution	PSN	6
1151101	water 98.3 % Ophthalmic Irrigation Solution	PSN	6
1424605	water 983 MG/ML Ophthalmic Irrigation Solution [Pur-Wash]	SBD	6
1151101	water 983 MG/ML Ophthalmic Irrigation Solution	SCD	6
1424605	Pur-Wash 98.3 % Ophthalmic Irrigation Solution	SY	6
1424605	Pur-Wash 983 MG/ML Ophthalmic Irrigation Solution	SY	6
1151101	water 98.3 % Ophthalmic Irrigation Solution	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65785-169-01	PUR-WASH	30 mL in 1 BOTTLE, UNIT-DOSE	SOLUTION	30		6
65785-169-04	PUR-WASH	118 mL in 1 BOTTLE, UNIT-DOSE	SOLUTION	118		6

Products#

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

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

PUR-WASH
Water
BORIC ACID
SODIUM CHLORIDE
SODIUM BORATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65785-169	65785-169-01, 65785-169-04

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
BORIC ACID	R57ZHV85D4	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
WATER	059QF0KO0R	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022305-001	PUR-WASH	PURIFIED WATER	98.3%	SOLUTION / OPHTHALMIC		RLD, RS	2011-09-01

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	beda35c3-9a8b-47ad-e053-2995a90a7b1b	2025-11-24	Warnings	Exact identifier ndc (package): 65785-169-01 ndc (package): 65785-169-04 ndc (product): 65785-169 ndc11 (package): 65785016904 ndc11 (package): 65785016901 spl id: 445c7592-5a84-c7eb-e063-6294a90a6a4a spl set id: beda35c3-9a8b-47ad-e053-2995a90a7b1b

Reported adverse events (FAERS/openFDA)#

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