Label: SYSTANE COMPLETE- propylene glycol solution/ drops

  • 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
  • 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 24, 2022

If you are a consumer or patient 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 solution/ drops
    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 finalpart34901/18/2018
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0481)