Label: SYSTANE- polyethylene glycol and propylene glycol solution/ drops
- NDC Code(s): 0065-0431-04, 0065-0431-32, 0065-0431-33, 0065-0431-57
- Packager: Alcon Research Ltd
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 15, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- PURPOSE
- 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
ORIGINAL PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Convenient
Single Vials
On-the-Go
Great for Sensitive Eyes
Refreshes & Lubricates
Soothing Comfort
#1 Doctor Recommended Brand1
STERILE
30 Vials 0.7 mL Each
Alcon
Side Panel (s)
SOOTHING COMFORT
SYSTANE® Original PF
Lubricant Eye Drops is scientifically
formulated to shield eyes from
dry eye discomfort so that
eyes feel refreshed.
LONG-LASTING RELIEF
SYSTANE® Original PF
Lubricant Eye Drops provides
long-lasting dry eye relief.
PRESERVATIVE-FREE
SYSTANE® Original PF
Lubricant Eye Drops comes in
convenient preservative-free vials
so you can enjoy relief from dry
eye anytime, anywhere.
TAMPER EVIDENT: Do not use if vial is
damaged or opened at time of purchase.
1 Based on a survey of eye care professionals.
Data on file.
www.alconpatents.com
Made in France
435241-0819Systane®
LUBRICANT EYE DROPS
ORIGINAL PF
PRESERVATIVE-FREE
DRY EYE RELIEF
DIRECTIONS:
Make sure container
is intact before use.
To open, COMPLETELY TWIST
OFF TAB.
Do not pull off.
Put 1 or 2 drops in the
affected eye(s) as needed.
Throw away container.
Do not reuse.
Manufactured for:
ALCON
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA -
INGREDIENTS AND APPEARANCE
SYSTANE
polyethylene glycol and propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0431 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 BORIC ACID (UNII: R57ZHV85D4) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) GUAR GUM (UNII: E89I1637KE) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) ZINC CHLORIDE (UNII: 86Q357L16B) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-0431-04 4 in 1 CARTON 10/30/2015 12/31/2017 1 0.4 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:0065-0431-32 28 in 1 CARTON 10/30/2015 12/31/2017 2 0.4 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:0065-0431-57 40 in 1 CARTON 10/30/2015 12/31/2017 3 0.4 mL in 1 VIAL; Type 0: Not a Combination Product 4 NDC:0065-0431-33 30 in 1 CARTON 10/30/2015 4 0.7 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 10/30/2015 Labeler - Alcon Research Ltd (008018525) Establishment Name Address ID/FEI Business Operations Kaysersberg Pharmaceuticals 267486052 manufacture(0065-0431)