Label: SYSTANE HYDRATION PF PRESERVATIVE FREE- polyethylene glycol 400 and propylene glycol solution/ drops
- NDC Code(s): 0065-1510-00, 0065-1510-06
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 23, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- Warnings
- Do not use
- When using this product
- STOP USE
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
-
Questions?
In the U.S. call 1 (800) 757-9195
www.systane.com
alcon.medinfo@alcon.comDirections for Use:
- Hold the bottle just below the cap and twist the cap to open.
- BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
- Shake the bottle downward to remove residual product (see picture).
- Place 1 or 2 drops in the affected eye(s) as needed and blink.
- After use, shake the bottle downward to remove residual product that may be left on the tip (see picture above).
- Replace cap after use.
- Discard 90 days after opening.
-
PRINCIPAL DISPLAY PANEL
Preservative-Free
SYSTANE®
Lubricant Eye Drops
HYDRATION PF
LONG LASTING
DRY EYE RELIEF
Dual Action Hydration
Extended Moisturizing
Preservative-Free Bottle
#1 Doctor Recommended Brands1
Alcon
STERILE 10 mL (0.34 FL OZ)
Side Panel
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
1Based on a survey of eye care professionals. Data on file.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin: USA
U.S. Pat: www.alconpatents.com
300068248-0824
Preservative-Free Bottle
SYSTANE®
Lubricant Eye Drops
HYDRATION PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Extra moisturizing for sensitive eyes
Longer lasting hydration*
#1 Doctor Recommended Brand1
Hydro Boost Technology
Alcon
STERILE 10 mL (0.34 FL OZ)
Side Panel
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
1Based on a survey of eye care professionals. Data on file.
*vs SYSTANE® ULTRA Lubricant Eye Drops
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin Belgium
www.alconpatents.com
300046319-0521
Preservative-Free
SYSTANE®
Lubricant Eye Drops
HYDRATION PF
LONG LASTING
DRY EYE RELIEF
Dual Action Hydration
Extended Moisturizing
Preservative-Free Bottle
#1 Doctor Recommended Brands1
Alcon
STERILE 10 mL (0.34 fl oz)
Side Panel
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
1Based on a survey of eye care professionals. Data on file.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin: Singapore
U.S. Pat.: www.alconpatents.com
300072081-0525
SYSTANE®
Lubricant Eye Drops
HYDRATION PF
LONG LASTING
DRY EYE RELIEF
STERILE
10mL (0.34 FL OZ)
Only for use in the eye.
Store at room temperature.
Discard 90 days after opening.
TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
See Carton for Directions For Use.Country of Origin: USA
LOT: EXP:
300068256-0824
SYSTANE®
Lubricant Eye Drops
HYDRATION PF
LONG LASTING
DRY EYE RELIEF
STERILE
10mL (0.34 fl oz)
Only for use in the eye.
Store at room temperature.
Discard 90 days after opening.
TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
See Carton for Directions For Use.
Country of Origin: Singapore
LOT: EXP:
300072094-0525
-
INGREDIENTS AND APPEARANCE
SYSTANE HYDRATION PF PRESERVATIVE FREE
polyethylene glycol 400 and propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1510 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) Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC) Potassium Chloride (UNII: 660YQ98I10) Water (UNII: 059QF0KO0R) Sodium Borate (UNII: 91MBZ8H3QO) Sodium Chloride (UNII: 451W47IQ8X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Sorbitol (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1510-06 1 in 1 CARTON 02/01/2021 1 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0065-1510-00 2 in 1 CARTON 01/11/2023 2 10 mL in 1 BOTTLE; 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 02/01/2021 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research, LLC 007672236 manufacture(0065-1510) Establishment Name Address ID/FEI Business Operations S.A. Alcon-Couvreur N.V. 370205429 manufacture(0065-1510) Establishment Name Address ID/FEI Business Operations Alcon Singapore Manufacturing Pte. Ltd. 595170137 manufacture(0065-1510)