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Systane by Alcon Research Ltd

Dosage form: solution/ drops
Ingredients: Polyethylene Glycol 400 4mg in 1mL, PROPYLENE GLYCOL 3mg in 1mL
Labeler: Alcon Research Ltd
NDC Code: 0065-0431

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Systane
Lubricant Eye Drops

Active Ingredients

Active IngredientsPurpose
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.
  • 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

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#1 Doctor Recommended Brand1

CONVENIENT PRESERVATIVE-FREE VIALS

Systane®
LUBRICANT EYE DROPS

PRESERVATIVE-FREE VIALS

LONG LASTING RELIEF
SOOTHING COMFORT
DRY EYE THERAPY

Alcon®
STERILE
28 Vials 0.4 mL (0.01 FL OZ) Each

ALL-DAY COMFORT.
Say good-bye to gritty, burning, dry eye discomfort. SYSTANE® Lubricant Eye Eye Drops forms a unique soft gel shield to keep eyes feeling fresh and moist all day long.

LONG-LASTING RELIEF
SYSTANE® Lubricant Eye Drops provides soothing relief that lasts and lasts and lasts.

PRESERVATIVE-FREE AND EASY.
SYSTANE® Lubricant Eye Drops comes in convenient preservative-free vials so you can enjoy freedom from dry eye anytime, anywhere.

Guaranteed.

SYSTANE® Lubricant Eye Drops is guaranteed to deliver long lasting relief from your dry eye symptoms. Prove it to yourself at no risk.

If SYSTANE® Lubricant Eye Drops does not provide you with the relief you expect, we will immediately send you a full refund, if you return the unused portion with evidence of price paid to:

Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134
Attn: Immediate and full refund

TAMPER EVIDENT:
Do not use if vial is damaged or opened.

Made in France
U.S. Patient Nos. 6,403,609, 6,583,124, and 6,838,449.
©2003-2004, 2006-2007, 2009 Alcon, Inc.

1 Survey of Ophthalmologists and Optometrists, Harris Interactive® December 2008.

Alcon®
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

427901

DIRECTIONS:
Make sure container is intact before use.
To open, COMPLETELEY TWIST OFF TAB.
Do not pull off.

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

Throw away container.
Do not reuse.

SYSTANE  
polyethylene glycol and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0431
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (Polyethylene Glycols) Polyethylene Glycol 4004 mg  in 1 mL
PROPYLENE GLYCOL (PROPYLENE GLYCOL) PROPYLENE GLYCOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
CALCIUM CHLORIDE 
GUAR GUM 
MAGNESIUM CHLORIDE 
POTASSIUM CHLORIDE 
WATER 
SODIUM CHLORIDE 
ZINC CHLORIDE 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:0065-0431-044 VIAL in 1 CARTON
10.4 mL in 1 VIAL
2NDC:0065-0431-3228 VIAL in 1 CARTON
20.4 mL in 1 VIAL
3NDC:0065-0431-5740 VIAL in 1 CARTON
30.4 mL in 1 VIAL
4NDC:0065-0431-3330 VIAL in 1 CARTON
40.7 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/14/2009
Labeler - Alcon Research Ltd (008018525)
Establishment
NameAddressID/FEIOperations
Kaysersberg Pharmaceuticals267486052manufacture(0065-0431)

Revised: 06/2016
 
Alcon Research Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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