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  5. Label Information: Systane Nighttime

FDA Label for Systane Nighttime

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT SECTION
    2. OTC - PURPOSE SECTION
    3. INDICATIONS & USAGE SECTION
    4. WARNINGS SECTION
    5. OTC - DO NOT USE SECTION
    6. OTC - WHEN USING SECTION
    7. OTC - STOP USE SECTION AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN SECTION
    9. DOSAGE & ADMINISTRATION SECTION
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT SECTION
    12. OTC - QUESTIONS SECTION
    13. PRINCIPAL DISPLAY PANEL

Systane Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. 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.

Otc - Active Ingredient Section



Mineral Oil 3%
White Petrolatum 94%


Otc - Purpose Section



Lubricant


Indications & Usage Section



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

Warnings Section



For external use only


Otc - Do Not Use Section



  • if you are sensitive to any ingredient in this product

Otc - When Using Section



  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using

Otc - Stop Use Section And Ask A Doctor If



  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Otc - Keep Out Of Reach Of Children Section



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


Dosage & Administration Section



Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.


Other Information



  • Store at 8°-27°C (46°-80°F).

Inactive Ingredient Section



Anhydrous Liquid Lanolin 3%.


Otc - Questions Section



In the U.S., call 1-800-757-9195 or visit www.systane.com


Principal Display Panel



FOR NIGHTTIME PROTECTION OF DRY EYES

Systane®
NIGHTTIME
LUBRICANT EYE OINTMENT

OVERNIGHT RELIEF

DRY EYE THERAPY

Systane®
NIGHTTIME
LUBRICANT EYE OINTMENT

Systane® Nighttime Lubricant Eye Ointment is a safe and effective formulation with no preservatives. This unpreserved ointment, when applied to the eyes, forms a smooth comfortable protective film, especially useful for nighttime protection and lubrication of dry eyes.

PRESERVATIVE-FREE

Alcon®
STERILE
3.5 g Tube (1/8 OZ NET WT)

Carton - carton

Carton - carton


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