Eyewash: Package Insert and Label Information

EYEWASH- water solution
Akorn, Inc.

Drug Facts

Active ingredient

Purified water 98.3%

Purpose

Eyewash

Use

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

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 you experience

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

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

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

Questions?

Call 888-628-0581

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, Inc.

Lake Forest, IL

60045

EHAAL Rev. 08/13

Made in Canada

Sterile Solution

4 fl.oz. (118 mL)

Principal Display Panel Text for Container Label
(click image for full-size original)
EYEWASH
water solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17478-620
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 929 g in 946 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
SODIUM BORATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17478-620-04 1 BOTTLE in 1 BOTTLE contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the BOTTLE (17478-620-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022305 06/01/2014
Labeler — Akorn, Inc. (062649876)
Registrant — Niagara Pharmaceuticals, Inc. (205477792)
Establishment
Name Address ID/FEI Operations
Niagara Pharmaceuticals, Inc. 205477792 manufacture (17478-620)

Revised: 11/2019 Akorn, Inc.

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