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
  • 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 June 30, 2022

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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
    • 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

    NEW
    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM RELIEF

    Convenient
    Single Vials
    On-the-Go

    Extra moisturizing for sensitive eyes
    Longer lasting hydration*

    #1 Doctor Recommended Brand1

    Hydro Boost     Technology

    STERILE
    30     Vials 0.7 mL (0.02 FL OZ)

    Alcon 
    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

    www.alconpatents.com
    Made in France 

    436270-0919

    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM 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.: 

    carton
    drug facts

    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM RELIEF

    Convenient
    Single Vials
    On-the-Go

    Extra moisturizing for sensitive eyes

    Longer lasting hydration*

    #1 Doctor Recommended Brand1

    Hydro
    Boost
    TECHNOLOGY

    Alcon
    STERILE
    30     Vials 0.7 mL (0.02 FL OZ)

    Alcon 
    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

    www.alconpatents.com
    Made in France 

    436271-0320 

    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM 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.: 

    carton2
    Back Label

    PRINCIPAL DISPLAY PANEL

    SYSTANE®
    Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM RELIEF

    Extra moisturizing for sensitive eye

    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)

    Alcon 
    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

    www.alconpatents.com
    Made in France 

    436272-0221

    SYSTANE® Lubricant Eye Drops

    HYDRATION PF
    PRESERVATIVE-FREE
    DRY EYE SYMPTOM 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 finalpart34902/01/2020
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-1437)
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