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

SYSTANE HYDRATION PF PRESERVATIVE FREE by

Drug Labeling and Warnings

SYSTANE HYDRATION PF PRESERVATIVE FREE by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., S.A. Alcon-Couvreur N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• 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

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

• 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.

Top of Carton:
SYSTANE®Lubricant Eye Drops

HYDRATION PF
PRESERVATIVE-FREE
DRY EYE RELIEF

Preservative-Free

PRINCIPAL DISPLAY PANEL

Preservative-Free

SYSTANE®
Lubricant Eye Drops

HYDRATION PF
PRESERVATIVE-FREE
DRY EYE RELIEF

Extra moisturizing for sensitive eyes
Longer lasting hydration*

Preservative-Free Bottle

#1 Doctor Recommended Brand1

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: USA
www.alconpatents.com

300059080-1022

Top of Carton:
SYSTANE® Lubricant Eye Drops

HYDRATION PF
PRESERVATIVE-FREE
DRY EYE RELIEF

PRINCIPAL DISPLAY PANEL

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

SYSTANE®
Lubricant Eye Drops

HYDRATION PF
PRESERVATIVE-FREE
DRY EYE RELIEF

STERILE
10mL (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: USA

LOT:               EXP:

300051436-0921

INGREDIENTS AND APPEARANCE

SYSTANE HYDRATION PF PRESERVATIVE FREE 
polyethylene glycol 400 and propylene glycol solution/ drops

Product 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)