Label: SYSTANE LUBRICANT- polyethylene glycol 400 and propylene glycol solution/ drops

  • NDC Code(s): 0065-0429-15, 0065-0429-21, 0065-0429-30, 0065-0429-36, view more
    0065-0429-67
  • 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 3, 2021

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 the temporary relief of burning and irritation due to 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

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • instill 1 or 2 drops in the affected eye(s) as needed
  • Other Information

    • store at room temperature
  • Inactive Ingredients:

    Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride.  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

    #1 Doctor Recommended Brand1 
    Systane
    ®
    LUBRICANT EYE DROPS

    LONG LASTING

    SOOTHING COMFORT
    DRY EYE THERAPY  

    Alcon 

    STERILE
    15 mL (1/2 FL OZ)

    TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck.
    Do not use if seal is damaged or missing at time of purchase.

    Country of Origin: Singapore

    www.alconpatents.com

    ©2018 Novartis

    Singapore Carton

    Systane®
    LUBRICANT EYE DROPS

    ORIGINAL
    LONG-LASTING 
    DRY EYE RELIEF   

    Refreshes & Lubricates
    Soothing Comfort

    #1 DOCTOR RECOMMENDED BRAND1

    Alcon
     
    STERILE
    15 mL (1/2 FL OZ)

    TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

    Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.

    SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

    ACTUAL SIZE

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

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

    www.alconpatents.com
    Made in USA from domestic and imported materials

    9016879-1118


    LOT:                EXP:

    Carton 9016879-1118

    Systane®
    LUBRICANT EYE DROPS

    ORIGINAL
    LONG-LASTING 
    DRY EYE RELIEF   

    Refreshes & Lubricates
    Soothing Comfort

    #1 DOCTOR RECOMMENDED BRAND1

    Alcon
     
    STERILE
    15 mL (1/2 FL OZ)

    TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

    Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.

    SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

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

    ACTUAL SIZE

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

    www.alconpatents.com
    Country of Origin: Singapore

    SC00264-0219


    LOT:                EXP:

    SC00264-0219
  • INGREDIENTS AND APPEARANCE
    SYSTANE LUBRICANT  
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0429
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) 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
    Boric Acid (UNII: R57ZHV85D4)  
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Guar Gum (UNII: E89I1637KE)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0429-151 in 1 CARTON02/25/2003
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-0429-212 in 1 CARTON02/25/200305/31/2021
    25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0065-0429-301 in 1 CARTON02/25/2003
    330 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:0065-0429-362 in 1 CARTON02/25/200308/31/2015
    430 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    5NDC:0065-0429-672 in 1 CARTON07/01/200804/30/2018
    520 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/25/2003
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research Ltd007672236manufacture(0065-0429)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Singapore Manufacturing Pte Ltd595170137manufacture(0065-0429)