SPL v5
SPL
SPL Set ID 6dc20e8a-cf22-43fd-af73-034e5e045b42
Route
OPHTHALMIC
Published
Effective Date 2015-02-12
Document Type 50577-6 OTC ANIMAL DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Water (929 g)
Inactive Ingredients
Boric Acid Sodium Borate Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-02-01

Description

Drug Facts

Purpose

Eyewash


Medication Information

Purpose

Eyewash

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 51945-4

Principal Display Panel Text for Container Label:

Akorn logo

OPHTHALMIC

SOLUTION

EYEWASH

Purified Water, 98.3%

NDC 59399-001-04

Single Use

FOR ANIMAL USE ONLY

Distributed by:

Akorn Operating Company LLC

Gurnee, IL

60031

EVAAL Rev. 07/22

Made in

Canada

Sterile

Solution

4 fl.oz. (118 mL)

Warnings

For external use only

Directions

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

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
Questions ?

Call 888-628-0581

Active Ingredient

Purified water 98.3%

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

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

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

Akorn logo

OPHTHALMIC

SOLUTION

EYEWASH

Purified Water, 98.3%

NDC 59399-001-04

Single Use

FOR ANIMAL USE ONLY

Distributed by:

Akorn Operating Company LLC

Gurnee, IL

60031

EVAAL Rev. 07/22

Made in

Canada

Sterile

Solution

4 fl.oz. (118 mL)

Purpose

Eyewash

Warnings

For external use only

Directions

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

Do Not Use (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
Questions ?

Call 888-628-0581

Active Ingredient (Active ingredient)

Purified water 98.3%

Other 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 Ingredients (Inactive ingredients)

boric acid, sodium borate, sodium chloride

When Using This Product (When using this product)
  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)