Medi-First First Aid Eye Wash — Solution

Overview

Brand name

Medi-First First Aid Eye Wash

Generic name

Purified Water

Dosage form

Solution

Route

Ophthalmic

Marketing category

NDA · NDA

Labeler

Unifirst First Aid Corporation

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

5

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	983 mg/mL	1053154	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Ophthalmic

Presentations

7

Regulatory status

Source: Drugs@FDA NDC 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 20250908). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250908

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Eyewash

Dosage and Administration

openFDA Drug Labeling

Directions Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle. .

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 immediare 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 you experience 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 immediare medical treatment if solution changes color or becomes cloudy

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if you experience 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.

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
47682-197-11	47682-197	Unifirst First Aid Corporation	473 mL in 1 BOTTLE, DISPENSING (47682-197-11)	October 1, 2015
47682-197-26	47682-197	Unifirst First Aid Corporation	946 mL in 1 BOTTLE, DISPENSING (47682-197-26)	January 1, 2016
47682-198-08	47682-198	Unifirst First Aid Corporation	236 mL in 1 BOTTLE, DISPENSING (47682-198-08)	December 2, 2011
47682-198-18	47682-198	Unifirst First Aid Corporation	118 mL in 1 BOTTLE, DISPENSING (47682-198-18)	December 2, 2011
47682-198-28	47682-198	Unifirst First Aid Corporation	30 mL in 1 BOTTLE, DISPENSING (47682-198-28)	December 2, 2011
47682-197	47682-197	Unifirst First Aid Corporation	—	October 1, 2015
47682-198	47682-198	Unifirst First Aid Corporation	—	December 2, 2011

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.