Opthalmic Solution Eyewash

Manufacturer
Hikma Pharmaceuticals USA Inc. | Niagara Pharmaceuticals Inc.
Effective date
2025-01-20
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:44:13

Label at a glance#

ProductOpthalmic Solution Eyewash
Active ingredientWATER
Label structure11 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water 98.3%

Purpose

OTC - PURPOSE SECTION

Eyewash

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard

OTC - STOP USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

boric acid, sodium borate, sodium chloride

Questions ?

OTC - QUESTIONS SECTION

☎ Call 833-850-7445

SPL UNCLASSIFIED SECTION

Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 86194-001-50

OPHTHALMIC
SOLUTION
EYEWASH

Purified Water, 98.3%

FOR ANIMAL USE ONLY

Single Use

Distributed by: Hikma

Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

EVAAL/01

Rev. 10/23

Made in Canada

Sterile Solution

4 fl.oz. (118 mL)

hikma.

animal health

image descriptionimage description

SPL UNCLASSIFIED SECTION

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1151101water 98.3 % Ophthalmic Irrigation SolutionPSN1
1151101water 983 MG/ML Ophthalmic Irrigation SolutionSCD1
1151101water 98.3 % Ophthalmic Irrigation SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86194-001-50Opthalmic Solution Eyewash30 mL in 1 BOTTLE, UNIT-DOSESOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86194-001OPTHALMIC SOLUTION EYEWASH (WATER) SOLUTION [HIKMA PHARMACEUTICALS USA INC.]11 package rows20250123_e287aa47-0cdb-4d21-ae29-78f86260fa56.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86194-00186194-001-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
V-BellaBORIC ACIDU.S. PHARMACEUTICAL CORPORATION3c3a423c-805d-4146-b16e-0138617a8dc62022-11-17WarningsName fallback
generic name: BORIC ACID

Reported adverse events (FAERS/openFDA)#

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