Systane Ultra Preservative Free
751fb85f-6683-4b0a-a650-324d4a74c5de
HUMAN OTC DRUG LABEL
Jul 30, 2025
Alcon Laboratories, Inc.
DUNS: 008018525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polyethylene Glycol 400 and Propylene Glycol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Preservative-Free
Systane**®******
****LUBRICANT EYE DROPS
ULTRA PF
****FAST ACTING
****DRY EYE RELIEF
Moisture Rich Formula
Instantly Hydrates
Preservative-Free Bottle
DOCTOR RECOMMENDED #1 BRANDS1
Alcon
STERILE
10 mL (0.34 FL OZ)
LOT: EXP.:
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 United States
U.S. Pat.: www.alconpatents.com
300068254-0824
****Actual Size
TWIN VALUE PACK
Preservative-Free
Systane**®******
****LUBRICANT EYE DROPS
ULTRA PF
****FAST ACTING
****DRY EYE RELIEF
Moisture Rich Formula
Instantly Hydrates
Preservative-Free Bottles
DOCTOR RECOMMENDED #1 BRANDS1
Alcon
STERILE
Two 10 mL (0.34 FL OZ) Bottles
LOT: EXP.:
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.
Preservative-Free
Fast Acting
Relief for
Sensitive Eyes
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin USA
U.S. Pat.: www.alconpatents.com
ACTUAL SIZE
300068255-0824
Preservative-Free****
Systane**®******
****LUBRICANT EYE DROPS
ULTRA PF****
FAST ACTING
DRY EYE RELIEF
Moisture Rich Formula
Instantly Hydrates
Preservative-Free Bottle
DOCTOR RECOMMENDED #1 BRANDS1
Alcon
STERILE
10 mL (0.34 fl oz)
LOT: EXP.:
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
300072082-0525
Actual Size
Systane®
LUBRICANT EYE DROPS
ULTRA PF
FAST ACTING
DRY EYE RELIEF
10 mL (0.34 FL OZ) STERILE
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:
300068258-0824
INDICATIONS & USAGE SECTION
Uses
- for the temporary relief of burning and irritation due to dryness of the eye
- for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
OTHER SAFETY INFORMATION
Other Information
- Store at room temperature
OTC - PURPOSE SECTION
|
Active Ingredients |
Purpose |
|
Polyethylene Glycol 400 0.4% |
Lubricant |
|
Propylene Glycol 0.3% |
Lubricant |
OTC - ACTIVE INGREDIENT SECTION
OTC - STOP USE SECTION
Stop use and ask a doctor ifyou 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
INACTIVE INGREDIENT SECTION
Inactive ingredients
Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
WARNINGS SECTION
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
OTC - WHEN USING SECTION
When using the product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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.
OTC - QUESTIONS SECTION
Questions?
In the U.S. call 1-800-757-9195
alcon.medinfo@alcon.com
www.systane.com