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

  • NDC Code(s): 0065-1437-04, 0065-1437-05
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

If you are a consumer or patient please visit this version.

  • 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
    • do not reuse
    • once opened, discard
  • 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. 
  • 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

  • PRINCIPAL DISPLAY PANEL

    SYSTANE®
    Lubricant Eye Drops


    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE RELIEF

    Convenient
    Single Vials
    On-the-Go

    Extra moisturizing for sensitive eyes

    Longer lasting hydration*

    VOTED PRODUCT OF THE YEAR
    Consumer Survey of Product Innovation
    2021±

    Hydro
    Boost

    TECHNOLOGY

    Alcon

    STERILE
    30
    Vials 0.7 mL (0.02 FL OZ)

    Experience
    preservative-free
    relief that’s extra
    moisturizing for
    sensitive eyes 


    Common Dry Eye Symptoms
    • Burning or stinging
    • Fluctuating vision
    • Irritation
    • Watery eyes

    TAMPER EVIDENT:
    For your protection, do not use if vial is damaged or opened at time of purchase.

    1 Based on a survey of eye care professionals.
    Data on file.

    * vs SYSTANE® ULTRA Lubricant Eye Drops

    ±Winner Eye Care Category. Survey of 40,000
    people by Kantar.

    www.alconpatents.com
    Made in France 

    436272-0221

    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE RELIEF

    DIRECTIONS: 

    Make sure container is intact before use.

    To open, COMPLETELY TWIST OFF TAB.

    Do not pull off. 

    Put 1 or 2 drops in the affected eye(s) as needed. 

    Throw away container. 
    Do not reuse. 


    ALCON
    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA

    LOT:
    EXP.: 

    Front Label
    Back Label
  • 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:0065-1437
    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:0065-1437-0430 in 1 CARTON02/01/2020
    10.7 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    2NDC:0065-1437-055 in 1 CARTON02/01/2020
    20.7 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01802/01/2020
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-1437)