SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]

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SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]
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NDC 0065-1431-05
Set ID 91379a76-fb7f-8357-7d75-7da54fd6d08e
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • OTC - ACTIVE INGREDIENT SECTION

    Polyethylene Glycol 400 0.4%
    Propylene Glycol 0.3%

  • OTC - PURPOSE SECTION

    Lubricant

  • INDICATIONS & USAGE SECTION

    • For the temporary relief of burning and irritation due to dryness of the eye
  • WARNINGS SECTION

    For external use only.

  • OTC - DO NOT USE SECTION

    Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
  • OTC - WHEN USING SECTION

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
  • OTC - STOP USE SECTION

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours
  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION SECTION

    • Shake well before using.
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • OTHER SAFETY INFORMATION

    • Store at room temperature.
  • INACTIVE INGREDIENT SECTION

    Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • OTC - QUESTIONS SECTION

    In the U.S. call 1-800-757-9195
    www.systane.com
    MedInfo@AlconLabs.com

  • PRINCIPAL DISPLAY PANEL

    Systane®
    ULTRA
    LUBRICANT EYE DROPS

    HIGH PERFORMANCE

    EXTENDED PROTECTION
    FAST SYMPTOM RELIEF

    #1 Doctor
    Recommended
    Brand1

    Alcon®

    STERILE
    10 mL (⅓ FL OZ)

    9006416-0111

    Carton
  • INGREDIENTS AND APPEARANCE
    SYSTANE ULTRA  
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1431
    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
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Boric Acid (UNII: R57ZHV85D4)  
    Guar Gum (UNII: E89I1637KE)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-1431-051 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/30/2009
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Laboratories, Inc.008018525MANUFACTURE(0065-1431)
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