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Systane

Alcon Research Ltd

SystaneLubricant Eye Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Polyethylene Glycol 400 0.4% . . . . . . . . . . . Lubricant

Propylene Glycol 0.3%. . . . . . . . . . . . . . . . . . Lubricant

Warnings

For external use only.

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard

Stop use 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

Keep out of reach of children.

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

Uses

For the temporary relief of burning and irritation due to dryness of the eye

Directions

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

Other Information

  • Store at room temperature.
  • Protect from light.

Inactive Ingredients

Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1-800-757-9195

www.systane.com MedInfo@AlconLabs.com

LUBRICANT EYE DROPS

43% MORE FREE!

#1 Doctor Recommended Brand1

Systane®

LUBRICANT EYE DROPS

PRESERVATIVE-FREE VIALS

LONG LASTING RELIEF

SOOTHING COMFORT

DRY EYE THERAPY

CONVENIENT PRESERVATIVE-FREE VIALS

Alcon®

STERILE

40 Vials 0.4 mL (0.01 FL OZ) Each

Systane

Systane

polyethylene glycol 0.4% and propylene glycol 0.3% SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0065-0431
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
polyethylene glycol POLYETHYLENE GLYCOL 0.4 mL
propylene glycol Propylene Glycol 0.3 mL

Inactive Ingredients

Ingredient Name Strength
BORIC ACID
calcium chloride
GUAR GUM
MAGNESIUM CHLORIDE
potassium chloride
water
SODIUM CHLORIDE
ZINC CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.4 in 1 VIAL
2 0.4 in 1 VIAL
3 0.4 in 1 VIAL
4 NDC:0065-0431-57 40 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2009-08-14


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