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Eyewash

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
Eyewash
Generic name
Eyewash
Dosage form
Solution
Route
Ophthalmic
Marketing category
DRUG FOR FURTHER PROCESSING · BULK API
Labeler
Global Equipment Company
Product type
Drug For Further Processing
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
9
Data completeness
76% 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 473 mL/473mL 1053154 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Ophthalmic
Presentations
12

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 20210617). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20210617

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

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

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

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

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
78641-786-67 78641-786 Global Equipment Company 473 mL in 1 BOTTLE, UNIT-DOSE (78641-786-67) June 17, 2021
78641-786-68 78641-786 Global Equipment Company 946 mL in 1 BOTTLE, UNIT-DOSE (78641-786-68) June 17, 2021
55718-178-01 55718-178 Isomedix Operations Inc 473 mL in 1 BOTTLE, UNIT-DOSE (55718-178-01) May 26, 2026
55718-178-02 55718-178 Isomedix Operations Inc 946 mL in 1 BOTTLE, UNIT-DOSE (55718-178-02) May 26, 2026
55718-178-03 55718-178 Isomedix Operations Inc 236 mL in 1 BOTTLE, UNIT-DOSE (55718-178-03) May 26, 2026
55718-178-04 55718-178 Isomedix Operations Inc 118 mL in 1 BOTTLE, UNIT-DOSE (55718-178-04) May 26, 2026
55718-178-05 55718-178 Isomedix Operations Inc 29 mL in 1 BOTTLE, UNIT-DOSE (55718-178-05) May 26, 2026
55718-123-01 55718-123 Isomedix Operations, Inc. 473 mL in 1 BOTTLE, UNIT-DOSE (55718-123-01) September 1, 2015
55718-123-02 55718-123 Isomedix Operations, Inc. 946 mL in 1 BOTTLE, UNIT-DOSE (55718-123-02) September 1, 2015
78641-786 78641-786 Global Equipment Company — June 17, 2021
55718-178 55718-178 Isomedix Operations Inc — September 29, 2025
55718-123 55718-123 Isomedix Operations, 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.