FDA Label for Eyewash

View Indications, Usage & Precautions

Eyewash Product Label

The following document was submitted to the FDA by the labeler of this product Akorn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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

Otc - Stop Use



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



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


Package Label.Principal Display Panel



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)


* Please review the disclaimer below.