ULINE EYEWASH- eyewash solution

ULINE Eyewash by

Drug Labeling and Warnings

ULINE Eyewash by is a Otc medication manufactured, distributed, or labeled by Niagara Pharmaceuticals Inc., Niagara Pharmaceuticals, Inc., STERIS Applied Sterilization Technologies ULC, Isomedix Operations Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Purified water 98.3%

Purpose

Eyewash

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

Use

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

Stop use and ask a doctor ifyou have any of the following

• continued redness or irritation of the eye
• condition worsens or persists
• eye pain
• changes in vision

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• remove tamper evident seal and cap
• flush the affected eye as needed, controlling the rate of flow of solution by presssure on the bottle

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 ingredients

boric acid, sodium borate, sodium chloride

Questions?

☎ Call 1.800.295.5510

Dosage & Administration

Remove Tamper evident seal and cap

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

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

ULINE EYEWASH 
eyewash solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65785-125
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	465 mL  in 473 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65785-125-01	473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	04/01/2024
2	NDC: 65785-125-02	946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022305	04/01/2024

Labeler - Niagara Pharmaceuticals Inc. (205477792)

Registrant - Niagara Pharmaceuticals Inc. (205477792)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals, Inc.		205477792	manufacture(65785-125)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Applied Sterilization Technologies ULC		243378155	sterilize(65785-125)

Establishment
Name	Address	ID/FEI	Business Operations
Isomedix Operations Inc		093889061	sterilize(65785-125)