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  5. Label Information: Artificial Tears

FDA Label for Artificial Tears

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Artificial Tears 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



Polyvinyl Alcohol 1.4%


Purpose



Eye lubricant


Uses



For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).


Otc - Do Not Use



  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

Stop Use And Ask A Doctor If



you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Instill 1 or 2 drops in the affected eye(s) as needed.


Other Information



  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients



Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.


Questions?



call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

NDC 17478-060-12

Artificial

Tears

Solution

Polyvinyl

Alcohol 1.4%

Lubricant

Eye Drops

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Carton Label:

NDC 17478-060-12

15 mL

Artificial

Tears

Solution

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

Prevents Irritation and Relieves

Dryness of the Eye

Sterile

15 mL (0.5 fl. oz.)


* Please review the disclaimer below.