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
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 30, 2022
If you are a consumer or patient please visit this version.
- 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
CONVENIENT PRESERVATIVE-FREE VIALS
#1 Doctor Recommended Brand1
Systane®
LUBRICANT EYE DROPS
PRESERVATIVE-FREE VIALS
LONG LASTING RELIEF
SOOTHING COMFORT
DRY EYE THERAPY
STERILE
30 Vials 0.7 mL Each
Alcon®
a Novartis companyPrincipal 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 final part349 10/30/2015 Labeler - Alcon Research Ltd (008018525) Establishment Name Address ID/FEI Business Operations Kaysersberg Pharmaceuticals 267486052 manufacture(0065-0431)