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Systane

Alcon Research Ltd

Systane ULTRALubricant Eye Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

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

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

Uses

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

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.

Directions

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

Other Information

  • Store at room temperature

Inactive Ingredients

Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

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

www.systane.com

LUBRICANT EYE DROPS

SEE DETAILS ON SIDE PANEL

CONVENIENT PRESERVATIVE-FREE VIALS

#1 Doctor Recommended Brand1

Systane® ULTRA

LUBRICANT EYE DROPS

HIGH PERFORMANCE

EXTENDED PROTECTION

FAST SYMPTOM RELIEF

PRESERVATIVE-FREE VIALS

Alcon®

STERILE

24 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:0065-1432
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
2-amino-2-methyl-1-propanol
BORIC ACID
GUAR GUM
potassium chloride
water
SODIUM CHLORIDE
sorbitol
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:0065-1432-03 72 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2009-07-27


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Be sure to consult your doctor before taking any medication!
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