Indications and uses
for use as a protectant against further irritation or to relieve dryness of the eye
Drug Facts
- Manufacturer
- Alcon Laboratories, Inc. | Alcon Research, LLC | S.A. Alcon-Couvreur N.V. | Alcon Singapore Manufacturing Pte. Ltd.
- Effective date
- 2026-08-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- daily-update
- Hydrated at
- 2026-08-13 01:01:20
Label at a glance#
ProductSYSTANE HYDRATION PF PRESERVATIVE FREE
Active ingredientPolyethylene Glycol 400, Propylene Glycol
Label structure12 sections
Dosage and administration
put 1 or 2 drops in the affected eye(s) as needed. see side of carton for directions for use
Contacts and useful links#
Websitewww.systane.com
www.systane.com
www.systane.comWebsitewww.alconpatents.com
www.alconpatents.com
www.alconpatents.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients | Purpose |
| Polyethylene Glycol 400 0.4% | Lubricant |
| Propylene Glycol 0.3% | Lubricant |
Uses
- for use as a protectant against further irritation or to relieve dryness of the eye
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
- replace cap after each use
OTC - STOP USE SECTION
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
- put 1 or 2 drops in the affected eye(s) as needed.
- see side of carton for directions for use
Other information
- store at room temperature
Inactive ingredients
aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, 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
alcon.medinfo@alcon.com
Directions 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.
1
Based 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
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0065-1510-00 | ML - Milliliter | 0065-1510 | 4457b33b-37b9-4725-8843-5f1669b2606c | 1 | 2023-03-13 |
| 0065-1510-06 | ML - Milliliter | 0065-1510 | 0bf98f6a-2576-4662-81c9-9356ca44d478 | 1 | 2021-04-08 |
Products#
Every source-derived product name is available through these pages.
- SYSTANE HYDRATION PF PRESERVATIVE FREE
- Polyethylene Glycol 400 and Propylene Glycol
- Polyethylene Glycol 400
- Polyethylene Glycol, Unspecified
- Propylene Glycol
- Aminomethylpropanol
- Boric Acid
- Guaraprolose (3500 Mpa.S At 1%)
- Potassium Chloride
- Water
- Sodium Borate
- Sodium Chloride
- Hyaluronate Sodium
- Hydrochloric Acid
- Sodium Hydroxide
- Sorbitol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0065-1510 | 0065-1510-06, 0065-1510-00, 0065-1510-85 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Polyethylene Glycol 400 | B697894SGQ | ACTIB |
| Propylene Glycol | 6DC9Q167V3 | ACTIB |
| Aminomethylpropanol | LU49E6626Q | IACT |
| Boric Acid | R57ZHV85D4 | IACT |
| Guaraprolose (3500 Mpa.S At 1%) | 3A1I7376TC | IACT |
| Potassium Chloride | 660YQ98I10 | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Borate | 91MBZ8H3QO | IACT |
| Sodium Chloride | 451W47IQ8X | IACT |
| Hyaluronate Sodium | YSE9PPT4TH | IACT |
| Hydrochloric Acid | QTT17582CB | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
| Sorbitol | 506T60A25R | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2025-07-23 | full-release | 2026-06-01 01:08:34 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SYSTANE HYDRATION PF PRESERVATIVE FREE | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 8936f66f-10fe-44ab-a26e-dd8b05dfa997 | 2026-08-10 | Warnings | 0065-1510-06 0065-1510-85 0065-1510-00 0065-1510 00065151085 00065151000 00065151006 088e37a3-666a-4442-b5db-0c17071a4d5e 8936f66f-10fe-44ab-a26e-dd8b05dfa997 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.