SYSTANE COMPLETE (PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]

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SYSTANE COMPLETE (PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]
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NDC 0065-0481-01, 0065-0481-10, 0065-0481-11, 0065-0481-55
Set ID 2df0de02-a3e2-471a-9e10-040c3fba75fe
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • 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)

    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)
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