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

  • NDC Code(s): 0065-1431-05
  • 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 21, 2011

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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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