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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. WARNINGS
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENT
    11. 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



Mineral Oil 15%

White Petrolatum 83%


Purpose



Eye lubricant

Eye lubricant


Uses



For use as a lubricant to prevent further irritation or to relieve dryness of the eyes.


Warnings



  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

Otc - Stop Use



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.


Otc - Keep Out Of Reach Of Children



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


Directions



Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.


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.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredient



Lanolin 2%


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

NDC 17478-062-35 Akorn Logo

Artificial Tears OINTMENT

Lubricant Eye Ointment

Sterile

FOR OPHTHALMIC USE ONLY Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Carton Label:

NDC 17478-062-35

3.5 g

Artificial

Tears

OINTMENT

Lubricant

Eye Ointment

Can Be Used at Bedtime

Sterile

Net Wt. 3.5 g (1/8oz.)


* Please review the disclaimer below.