SYSTANE ULTRA- polyethylene glycol 400 and propylene glycol solution/ drops 
Alcon Laboratories, Inc.

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Drug Facts

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

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 experience any of the following:

  • eye pain
  • changes in vision
  • Continued redness or irritation of the eye
  • Condition worsens or persists for more than 72 hours

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

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

Systane®
LUBRICANT EYE DROPS    

ULTRA PF


PRESERVATIVE-FREE
DRY EYE RELIEF

Convenient Single Vials On-The-Go

Great for sensitive eyes

Fast-acting hydration
and lasting relief

Moisture-rich formula

#1 Doctor Recommended Brand1

STERILE
60 Vials 0.7 mL Each

Alcon

SIDE DISPLAY PANEL

Systane®
LUBRICANT EYE DROPS

ULTRA PF

PRESERVATIVE-FREE
DRY EYE RELIEF

Convenient Single Vials On-The-Go

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 have 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 at time of purchase.

1Based on a survey of eye care professionals. Data on file.

www.alconpatents.com
Made in France

W435221-0919

Carton Label
SYSTANE  ULTRA
polyethylene glycol 400 and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1432
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol, Unspecified - UNII:3WJQ0SDW1A) Polyethylene Glycol 4004 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aminomethylpropanol (UNII: LU49E6626Q)  
BORIC ACID (UNII: R57ZHV85D4)  
GUAR GUM (UNII: E89I1637KE)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-1432-0124 in 1 CARTON07/27/200912/31/2017
10.4 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:0065-1432-024 in 1 CARTON07/27/200912/31/2017
20.4 mL in 1 VIAL; Type 0: Not a Combination Product
3NDC:0065-1432-0372 in 1 CARTON07/27/200912/31/2017
30.4 mL in 1 VIAL; Type 0: Not a Combination Product
4NDC:0065-1432-045 in 1 CARTON07/27/2009
4.7 mL in 1 VIAL; Type 0: Not a Combination Product
5NDC:0065-1432-0560 in 1 CARTON07/27/2009
5.7 mL in 1 VIAL; Type 0: Not a Combination Product
6NDC:0065-1432-0625 in 1 CARTON07/27/2009
6.7 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01807/27/2009
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Kaysersberg Pharmaceuticals267486052manufacture(0065-1432)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoire Unither574139809manufacture(0065-1432)

Revised: 12/2023
Document Id: cce3e663-58ef-4ece-a6d2-c49ecc7ea9cb
Set id: a5c1c194-3db5-4f18-9cd1-97f7f84c3cff
Version: 15
Effective Time: 20231215
 
Alcon Laboratories, Inc.