Label: SYSTANE COMPLETE- propylene glycol emulsion

  • NDC Code(s): 0065-0481-01, 0065-0481-10, 0065-0481-11, 0065-0481-55, view more
    0065-0481-72
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 2, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Propylene Glycol 0.6%Lubricant

  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    • for use as a protectant against further irritation or to relieve dryness of the eye
    • for use as a lubricant to prevent further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

    Do not use

    • if this product changes color
    • 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 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

    • shake well before using
    • put 1 or 2 drops in the affected eye(s) as needed
  • Other Information

    • store at room temperature
  • Inactive Ingredients

    boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD® (polyquaternium-1) 0.001% preservative,  sorbitan tristearate, sorbitol and purified water.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions?

    In the U.S. call 1-800-757-9195
    alcon.medinfo@alcon.com
    www.systane.com

  • PRINCIPAL DISPLAY PANEL

    Systane® 
    LUBRICANT EYE DROPS

    COMPLETE
    OPTIMAL DRY EYE RELIEF

    Fast-acting hydration
    Tear evaporation protection
    Nano-droplets for better coverage*  

    #1 DOCTOR RECOMMENDED BRAND1

    nano droplet  

    Alcon

    STERILE

    10mL (1/3 FL OZ)

    LOT:                    EXP.:

    SIDE PANEL

    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.

    SYSTANE®
    COMPLETE

    Our most advanced
    formula ever!


    SYSTANE®
    COMPLETE
    Lubricant
    Eye Drops

    hydrates
    fast, protects
    against tear
    evaporation, and
    helps support all layers
    of the tear film.

    Nano droplet technology:*

    ● a better delivery of the
    active ingredient
    ● better eye coverage

    ACTUAL SIZE

    Alcon
    Alcon Laboratories, Inc.
    Fort Worth, TX 76143 USA

    * vs SYSTANE® BALANCE

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

    www.alconpatents.com

    Made in USA from domestic and imported materials

    300048645-0621

    Systane Caron 300048645-0621 10mL

    Systane® 
    LUBRICANT EYE DROPS

    COMPLETE
    OPTIMAL DRY EYE RELIEF

    Fast-acting hydration
    Tear evaporation protection
    Nano-droplets for better coverage*  

    #1 DOCTOR RECOMMENDED BRAND1

    nano droplet  

    Alcon

    STERILE

    10mL (1/3 FL OZ)

    SIDE PANEL

    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.

    Systane®COMPLETE

    Our most advanced formula ever!

    Systane® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film.

    Nano droplet technology*
    ● a better delivery of the active ingredient
    ● better eye coverage

    * vs Systane®BALANCE

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

    www.alconpatents.com

    ©2018 Novartis

    Made in USA from domestic and imported materials

    9015757-0418

    Alcon
    Alcon Laboratories, Inc.
    Fort Worth, TX 76143 USA

    Systane COMPLETE Carton
  • INGREDIENTS AND APPEARANCE
    SYSTANE COMPLETE 
    propylene glycol emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0481
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol.06 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Boric Acid (UNII: R57ZHV85D4)  
    Dimyristoylphosphatidylglycerol, Dl- (UNII: BI71WT9P3R)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Guar Gum (UNII: E89I1637KE)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)  
    Sorbitan Tristearate (UNII: 6LUM696811)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0481-101 in 1 CARTON01/18/2018
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-0481-112 in 1 CARTON01/18/2018
    210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0065-0481-011 in 1 CARTON01/18/2018
    31.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:0065-0481-551 in 1 CARTON01/18/2018
    45 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    5NDC:0065-0481-723 in 1 CARTON01/18/2018
    510 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 DrugM01801/18/2018
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0481)