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

  • NDC Code(s): 0065-1510-00, 0065-1510-06
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 8, 2023

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    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 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).
    Use Diagram
    • 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.

    300039850-0920

    Top of Carton:
    SYSTANE® Lubricant Eye Drops


    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM RELIEF

  • PRINCIPAL DISPLAY PANEL

    New! Preservative-Free Bottle

    SYSTANE® Lubricant Eye Drops 

    HYDRATION PF      
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM RELIEF     

    Extra moisturizing for sensitive eyes   
    Longer lasting hydration*

    #1 Doctor Recommended Brand1
    Hydro Boost Technology 

    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.   
    *vs SYSTANE® ULTRA Lubricant Eye Drops     

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

    300039850-0920

    Carton Image

    300046319-0521

    Top of Carton:
    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM RELIEF

    PRINCIPAL DISPLAY PANEL

    Preservative-Free Bottle

    SYSTANE®
    Lubricant Eye Drops     

    HYDRATION PF      
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM 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

    300051437-0921

    Top of Carton:
    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
     PRESERVATIVE-FREE
    DRY EYE SYMPTOM RELIEF    

    Preservative-Free Bottle

    SYSTANE®
    Lubricant Eye Drops 

    HYDRATION PF      
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM 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: USA   

    www.alconpatents.com

    300051437-0921

    300051437-0921
  • INGREDIENTS AND APPEARANCE
    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 finalpart34902/01/2021
    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)
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