SYSTANE ULTRA PRESERVATIVE FREE- polyethylene glycol 400 and propylene glycol solution/ drops

Systane Ultra Preservative Free by

Drug Labeling and Warnings

Systane Ultra Preservative Free by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

• Active Ingredients: Purpose
• Polyethylene Glycol 400 0.4%: Lubricant
• Propylene Glycol 0.3%: Lubricant

ACTIVE INGREDIENT

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
  

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 the product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

STOP USE

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

• shake well before using
• 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 chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1-800-757-9195
alcon.medinfo@alcon.com
www.systane.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.

PRINCIPAL DISPLAY PANEL

Preservative-Free

Systane®
LUBRICANT EYE DROPS
ULTRA PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Fast-acting hydration and lasting relief
Moisture rich formula for sensitive eyes
Preservative-Free Bottle

DOCTOR RECOMMENDED #1 Brand1

STERILE
10 mL (0.34 FL OZ)
Alcon

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.

300059081-1022

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
www.alconpatents.com

PRINCIPAL DISPLAY PANEL

TWIN PACK

Preservative-Free

Systane®
LUBRICANT EYE DROPS

ULTRA PF
PRESERVATIVE-FREE
DRY EYE RELIEF

Fast-acting hydration and lasting relief
Moisture rich formula for sensitive eyes

Preservative-Free Bottles

DOCTOR RECOMMENDED #1 Brand1

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.


Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin USA
www.alconpatents.com

ACTUAL SIZE

300059122-1022

Systane®
LUBRICANT EYE DROPS

ULTRA PF
PRESERVATIVE-FREE
DRY EYE RELIEF

STERILE
10 mL (0.34 FL OZ)  

Only for use in the eye.

Store at room temperature.

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 United States

LOT:               EXP:

300049451-0721

INGREDIENTS AND APPEARANCE

SYSTANE ULTRA PRESERVATIVE FREE 
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-1507
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	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 Chloride (UNII: 451W47IQ8X)
Sorbitol (UNII: 506T60A25R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-1507-82	1 in 1 CARTON	02/15/2022
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-1507-92	2 in 1 CARTON	04/11/2023
2		10 mL in 1 BOTTLE, DROPPER; 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	02/15/2022

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-1507)