Label: SYSTANE ULTRA- polyethylene glycol 400 and propylene glycol solution/ drops
-
NDC Code(s):
0065-1432-01,
0065-1432-02,
0065-1432-03,
0065-1432-04, view more0065-1432-05, 0065-1432-06
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 15, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- 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
- Directions
- Other Information
- Inactive Ingredients
- Questions?
-
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
AlconSIDE 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
-
INGREDIENTS AND APPEARANCE
SYSTANE ULTRA
polyethylene glycol 400 and propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1432 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol, Unspecified - UNII:3WJQ0SDW1A) Polyethylene Glycol 400 4 mg in 1 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1432-01 24 in 1 CARTON 07/27/2009 12/31/2017 1 0.4 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:0065-1432-02 4 in 1 CARTON 07/27/2009 12/31/2017 2 0.4 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:0065-1432-03 72 in 1 CARTON 07/27/2009 12/31/2017 3 0.4 mL in 1 VIAL; Type 0: Not a Combination Product 4 NDC:0065-1432-04 5 in 1 CARTON 07/27/2009 4 .7 mL in 1 VIAL; Type 0: Not a Combination Product 5 NDC:0065-1432-05 60 in 1 CARTON 07/27/2009 5 .7 mL in 1 VIAL; Type 0: Not a Combination Product 6 NDC:0065-1432-06 25 in 1 CARTON 07/27/2009 6 .7 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 07/27/2009 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Kaysersberg Pharmaceuticals 267486052 manufacture(0065-1432) Establishment Name Address ID/FEI Business Operations Laboratoire Unither 574139809 manufacture(0065-1432)