Kollourion Eyesalve Eyewash

Manufacturer: Miracle Eye Pharmaceuticals | Niagara Pharmaceuticals Inc
Effective date: 2025-12-28
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:28:55

Label at a glance#

ProductKollourion Eyesalve Eyewash

Active ingredientWATER

Label structure10 sections

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

PhoneLabel contact1-973-568-3361

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Purified Water 98.3%

OTC - PURPOSE SECTION

Purpose

Eyewash

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

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.
continued redness or irritation of the eye
condition worsens or persists

eye pain
changes in vision

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.

DOSAGE & ADMINISTRATION SECTION

Directions

flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

OTHER SAFETY INFORMATION

Other information

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 INGREDIENT SECTION

Inactive ingredients

boric acid, sodium borate, sodium chloride

OTC - QUESTIONS SECTION

Call 1-973-568-3361 9am to 5pm EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 2label 3label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1151101	water 98.3 % Ophthalmic Irrigation Solution	PSN	8
1151101	water 983 MG/ML Ophthalmic Irrigation Solution	SCD	8
1151101	water 98.3 % Ophthalmic Irrigation Solution	SY	8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72924-001-01	Kollourion Eyesalve Eyewash	1 in 1 CARTON	SOLUTION	1		8
72924-001-01	Kollourion Eyesalve Eyewash	30 mL in 1 BOTTLE	SOLUTION	30		8

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Kollourion Eyesalve Eyewash
Purified Water 98.3%
SODIUM CHLORIDE
SODIUM BORATE
WATER
BORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72924-001	72924-001-01
65785-160

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
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
WATER	059QF0KO0R	ACTIB
BORIC ACID	R57ZHV85D4	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
5	2024-12-26	full-release	2026-06-01 00:49:16

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kollourion Eyesalve Eyewash	PURIFIED WATER 98.3%	Miracle Eye Pharmaceuticals	b56d2ab9-169b-b490-e053-2a95a90a80b3	2025-12-28	Warnings	Exact identifier ndc (package): 72924-001-01 ndc (product): 72924-001 ndc11 (package): 72924000101 spl id: 4709e35f-04bb-30b0-e063-6294a90a8288 spl set id: b56d2ab9-169b-b490-e053-2a95a90a80b3
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	e07a064b-f680-405c-bbcd-24fac430951e	2025-11-24	Warnings	Exact identifier ndc (product): 65785-160

Reported adverse events (FAERS/openFDA)#

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