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

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

NDC 0065-1431-01, 0065-1431-05, 0065-1431-18, 0065-1431-21, 0065-1431-28, 0065-1431-31, 0065-1431-41, 0065-1431-80
Set ID 0537c23a-15f7-be64-1231-a6c93468e9a8
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Polyethylene Glycol 400 0.4%Lubricant
    Propylene Glycol 0.3%Lubricant
  • Uses

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

    For external use only                 

  • Do not use

    • if this product changes color or becomes cloudy
    • 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

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

  • Questions?

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Polyethylene Glycol 400 0.4%Lubricant
    Propylene Glycol 0.3%Lubricant
  • Uses

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

    For external use only.

  • Do Not Use

    • if this product changes color or becomes cloudy
    • 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 feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts 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.
  • Other Information

    • Instill 1 or 2 drops in the affected eye(s) as needed.
    • Store at room temperature.
  • Inactive Ingredients

    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.

  • Questions?

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

  • Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active IngredientsPurpose
    Polyethylene Glycol 400 0.4%Lubricant
    Propylene Glycol 0.3%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
  • Warnings

    For external use only

  • Do not use

    • if this product changes color or becomes cloudy
    • 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

    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

    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

    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.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Systane*
    ULTRA
    LUBRICANT EYE DROPS


    HIGH PERFORMANCE

    EXTENDED PROTECTION
    FAST SYMPTOM RELIEF

    #1 Doctor
    Recommended
    Dry Eye Brand


    Alcon®
    STERILE
    3 mL (0.1 FL OZ)

    Systane Ultra Carton Image

    Systane® ULTRA
    LUBRICANT EYE DROPS

    HIGH PERFORMANCE
    EXTENDED PROTECTION
    FAST SYMPTOM RELIEF

    #1 Doctor Recommended Brand1

    Alcon
    STERILE
    3mL (0.1 FL OZ)

    carton

    Systane® ULTRA
    LUBRICANT EYE DROPS

    HIGH PERFORMANCE
    EXTENDED PROTECTION
    FAST SYMPTOM RELIEF

    #1 Doctor Recommended Brand1

    Alcon
    STERILE 
    10  mL (⅓ FL OZ)

    carton 0065-1431-05

    Systane® 
    LUBRICANT EYE DROPS

    ULTRA
    HIGH PERFORMING DRY EYE RELIEF

    Fast-acting hydration and lasting relief

    Moisture rich formula

    #1 Doctor Recommended Brand1

    Alcon

    STERILE
     

    10  mL (1/3 FL OZ)

    systane-ultra-0065-1431-05-singapore
  • 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:0065-1431-801 in 1 CARTON10/01/2014
    13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-1431-011 in 1 CARTON10/01/2014
    21.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0065-1431-051 in 1 CARTON10/01/2014
    310 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:0065-1431-183 in 1 CARTON10/01/2014
    410 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    5NDC:0065-1431-211 in 1 CARTON10/01/2014
    53 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    6NDC:0065-1431-282 in 1 CARTON10/01/2014
    64 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    7NDC:0065-1431-311 in 1 CARTON10/01/2014
    74 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    8NDC:0065-1431-412 in 1 CARTON10/01/2014
    810 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 finalpart34910/01/2014
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-1431)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Singapore Manufacturing Pte Ltd595170137manufacture(0065-1431)