SYSTANE HYDRATION PF PRESERVATIVE FREE- polyethylene glycol 400 and propylene glycol solution/ drops 
Alcon Laboratories, Inc.

----------

Drug Facts

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

Warnings

For external use only                 

Do not use

When using this product

Stop use and ask a doctor if you experience any of the following:

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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:

Use Diagram

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

Carton Image

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

Part 300046319

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

Carton Image

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

Bottle Image

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

Bottle Image
SYSTANE HYDRATION PF PRESERVATIVE FREE 
polyethylene glycol 400 and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1510
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol, Unspecified - UNII:3WJQ0SDW1A) Polyethylene Glycol 4004 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-1510-061 in 1 CARTON02/01/2021
110 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0065-1510-002 in 1 CARTON01/11/2023
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01802/01/2021
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research, LLC007672236manufacture(0065-1510)
Establishment
NameAddressID/FEIBusiness Operations
S.A. Alcon-Couvreur N.V.370205429manufacture(0065-1510)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Singapore Manufacturing Pte. Ltd.595170137manufacture(0065-1510)

Revised: 7/2025
Document Id: aeb3df48-7af2-464e-a87d-fe9027452a85
Set id: 8936f66f-10fe-44ab-a26e-dd8b05dfa997
Version: 8
Effective Time: 20250723
 
Alcon Laboratories, Inc.