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PUR-WASH

Water · Solution

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PUR-WASH
Generic name
Water
Dosage form
Solution
Route
Ophthalmic
Marketing category
NDA · NDA
Labeler
Niagara Pharmaceuticals Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
5
Packages
10
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Water 465 mL/473mL 1053154 View
Water 929 g/946mL 1053154 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Ophthalmic
Presentations
15

Regulatory status

Source: Drugs@FDANDC Directory
Application number
022305
Application type
NDA · New Drug Application
Approval date
September 1, 2011
Sponsor
NIAGARA PHARMS
Products on application
1
Submissions recorded
6
Products approved under application 022305.
Product Trade name Form Strength Ingredient Status TE Flags
022305-001 PUR-WASH SOLUTION PURIFIED WATER Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 022305.
Type No. Action Status Date Review
Supplement 8 Labeling Approved February 2, 2026 Standard
Supplement 7 Labeling Approved June 26, 2025 Standard
Supplement 6 Labeling Approved December 12, 2019 Standard
Supplement 4 Manufacturing (CMC) Approved January 7, 2015 Standard
Supplement 1 Manufacturing (CMC) Approved September 26, 2013 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved September 1, 2011 Standard

Review documents

  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · June 27, 2025
  • 0 · Original application · June 26, 2012
  • 0 · Original application · June 26, 2012
  • 0 · Original application · September 16, 2011

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251124). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251124 HUMAN OTC DRUG · 20251124 HUMAN OTC DRUG · 20251124

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Eyewash

Dosage and Administration

openFDA Drug Labeling

Directions • 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

Warnings and Cautions

openFDA Drug Labeling

Warnings 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

Warnings

openFDA Drug Labeling

Warnings 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 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

Stop use and ask a doctor if you have any of the following continued redness or irritation of the eye condition worsens or persists eye pain changes in vision

Stop Use

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

Active ingredient Purified water 98.3%

Adverse event reports

Source: openFDA FAERS
19,134
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: WATER. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
65785-160-01 65785-160 Niagara Pharmaceuticals Inc. 30 mL in 1 BOTTLE, UNIT-DOSE (65785-160-01) September 12, 2011
65785-160-02 65785-160 Niagara Pharmaceuticals Inc. 118 mL in 1 BOTTLE, UNIT-DOSE (65785-160-02) September 12, 2011
65785-162-01 65785-162 Niagara Pharmaceuticals Inc. 236 mL in 1 BOTTLE, UNIT-DOSE (65785-162-01) September 12, 2011
65785-162-02 65785-162 Niagara Pharmaceuticals Inc. 473 mL in 1 BOTTLE, UNIT-DOSE (65785-162-02) September 12, 2011
65785-166-01 65785-166 Niagara Pharmaceuticals Inc. 473 mL in 1 BOTTLE, UNIT-DOSE (65785-166-01) May 24, 2013
65785-166-02 65785-166 Niagara Pharmaceuticals Inc. 946 mL in 1 BOTTLE, UNIT-DOSE (65785-166-02) May 24, 2013
65785-169-01 65785-169 Niagara Pharmaceuticals Inc. 30 mL in 1 BOTTLE, UNIT-DOSE (65785-169-01) September 12, 2011
65785-169-04 65785-169 Niagara Pharmaceuticals Inc. 118 mL in 1 BOTTLE, UNIT-DOSE (65785-169-04) September 12, 2011
65785-168-01 65785-168 Niagara Pharmaceuticals, Inc. 473 mL in 1 BOTTLE, UNIT-DOSE (65785-168-01) September 1, 2015
65785-168-02 65785-168 Niagara Pharmaceuticals, Inc. 946 mL in 1 BOTTLE, UNIT-DOSE (65785-168-02) September 1, 2015
65785-160 65785-160 Niagara Pharmaceuticals Inc. — September 12, 2011
65785-162 65785-162 Niagara Pharmaceuticals Inc. — September 12, 2011
65785-166 65785-166 Niagara Pharmaceuticals Inc. — May 24, 2013
65785-169 65785-169 Niagara Pharmaceuticals Inc. — September 12, 2011
65785-168 65785-168 Niagara Pharmaceuticals, Inc. — January 30, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.