bdc2d61a-b403-4263-85cb-d524cc7c6334

SPL v6
SPL
SPL Set ID bdc2d61a-b403-4263-85cb-d524cc7c6334
Route
ophthalmic
Published
Effective Date 2022-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
water (929 g)
Inactive Ingredients
boric acid sodium borate sodium chloride

Identifiers & Packaging

Marketing Status
nda active Since 2014-06-01

Purpose

Eyewash

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

Eyewash

Directions

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

Description

Drug Facts

Questions?

Call 888-628-0581

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 17478-620-04

Single Use

Distributed by:

Akorn Operating Company LLC

Gurnee, IL

60031

EHAAL Rev. 07/22

Made in Canada

Sterile Solution

4 fl.oz. (118 mL)

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
Active Ingredient

Purified water 98.3%

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

Warnings

For external use only

Purpose

Eyewash

Directions

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

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

Questions?

Call 888-628-0581

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 17478-620-04

Single Use

Distributed by:

Akorn Operating Company LLC

Gurnee, IL

60031

EHAAL Rev. 07/22

Made in Canada

Sterile Solution

4 fl.oz. (118 mL)

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
Active Ingredient (Active ingredient)

Purified water 98.3%

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)