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Systane ULTRA by Alcon Laboratories, Inc.

Medically reviewed on March 5, 2018

Dosage form: solution/ drops
Ingredients: Polyethylene Glycol 400 4mg in 1mL, PROPYLENE GLYCOL 3mg in 1mL
Labeler: Alcon Laboratories, Inc.
NDC Code: 0065-1432

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 ULTRA
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

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

PRINCIPAL DISPLAY PANEL

#1 Doctor Recommended Brand1

CONVENIENT PRESERVATIVE-FREE  VIALS

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

Open your eyes to a breakthrough in comfort with SYSTANE® ULTRA Lubricant Eye Drops.

SYSTANE® ULTRA preservative-free vials elevates the science of dry eye therapy to a new level so you can feel relief from dry eye anytime, anywhere.

From first blink, eyes feel lubricated and refreshed. Feel the difference in dry eye relief with SYSTANE® ULTRA.

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

Made in France

U.S. Patent Nos 6,403,609, 6,583,124 and 6,838,449.
© 2009-2010 Alcon, Inc.

429930


Alcon®

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

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

Systane ULTRA LUBRICANT EYE DROPS

DIRECTIONS:
Make sure container is intact before use. To open, COMPLETELY 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  ULTRA
polyethylene glycol 400 and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1432
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
Aminomethylpropanol 
BORIC ACID 
GUAR GUM 
POTASSIUM CHLORIDE 
WATER 
SODIUM CHLORIDE 
SORBITOL 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:0065-1432-0124 VIAL in 1 CARTON
10.4 mL in 1 VIAL
2NDC:0065-1432-024 VIAL in 1 CARTON
20.4 mL in 1 VIAL
3NDC:0065-1432-0372 VIAL in 1 CARTON
30.4 mL in 1 VIAL
4NDC:0065-1432-045 VIAL in 1 CARTON
4.7 mL in 1 VIAL
5NDC:0065-1432-0560 VIAL in 1 CARTON
5.7 mL in 1 VIAL
6NDC:0065-1432-0625 VIAL in 1 CARTON
6.7 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/27/2009
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIOperations
Kaysersberg Pharmaceuticals267486052manufacture(0065-1432)
Establishment
NameAddressID/FEIOperations
Laboratoire Unither574139809manufacture(0065-1432)

 
Alcon Laboratories, Inc.

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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