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PEG-Phen Ultra Lubricant Eye Drops (Amerisource Bergen)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 2 BOTTLE, DROPPER in 1 CARTON (46122-201-92) > 10 mL in 1 BOTTLE, DROPPER Label Information

Complete PEG-Phen Ultra Lubricant Eye Drops Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    Polyethylene Glycol 400 0.4%

    Propylene Glycol 0.3%


  • Purpose

    Lubricant

    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
    • Instill 1 or 2 drops in the affected eye(s) as needed.

  • Other Information

    • Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

  • Inactive Ingredients:

    Purified Water, Sorbitol solution, Boric Acid, 2-amino-2-methyl-1-propanol, Hypromellose USP, Sodium Chloride, Potassium Chloride. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

    Preservative: Benzalkonium Chloride.


  • QUESTIONS

    Figure
Questions or comments? 1-800-579-8327


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    46122-201-92

    Good Neighbor Pharmacy Logo ®

    Ultra Lubricant

    Eye Drops

    PEG-Phen Ultra Lubricant Eye Drops

    10 mL (0.3 fl oz)

    Sterile

    Principal Display Panel Text for Container Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    46122-201-92

    Compare to

    Systane® Ultra

    active ingredients*

    Good Neighbor Pharmacy Logo ®

    TWIN PACK

    Ultra

    Lubricant

    Eye Drops

    PEG-Phen Ultra

    Lubricant Eye Drops

    2 – 10 mL bottles

    (0.6 fl oz total)

    Sterile

    Principal Display Panel Text for Carton Label

  • INGREDIENTS AND APPEARANCE
    PEG-PHEN ULTRA LUBRICANT EYE DROPS 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-201
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 400 4 mg  in 1 mL
    Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Boric Acid (UNII: R57ZHV85D4)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-201-92 2 in 1 CARTON
    1 10 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 03/22/2013
    Labeler - Amerisource Bergen (007914906)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(46122-201) , ANALYSIS(46122-201) , STERILIZE(46122-201) , PACK(46122-201) , LABEL(46122-201)