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

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.

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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 finalpart34907/27/2009
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Kaysersberg Pharmaceuticals267486052manufacture(0065-1432)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoire Unither574139809manufacture(0065-1432)

Revised: 12/2022
Document Id: 0652d5f3-8712-4c77-8378-c70ae2dd8057
Set id: a5c1c194-3db5-4f18-9cd1-97f7f84c3cff
Version: 14
Effective Time: 20221222
 
Alcon Laboratories, Inc.