Label: LUBRICATING RELIEF- polyethylene glycol 400 and propylene glycol solution/ drops 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Polyethylene Glycol 400 0.4%

    Propylene Glycol 0.3%

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  • Purpose

    Lubricant

    Lubricant

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  • Uses

    • For the temporary relief of burning and irritation due to dryness of the eye.
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  • 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 (1 -800-222-1222).

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  • Directions

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

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

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  • 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.

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  • Questions or comments?

    1-800-632-6900

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    30142-327-04

    Kroger Logo® STERILE

    eye drops

    lubricating relief

    Polyethylene Glycol 400 0.4%/Propylene Glycol 0.3%

    10 mL (0.3 FL OZ)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    COMPARE TO the active Ingredients of

    SYSTANE ULTRA®*See side panel

    30142-327-04

    Kroger Logo®

    FROM OUR FAMILY

    TO YOURS

    STERILE

    eye drops

    lubricating

    relief

    Polyethylene Glycol 400 0.4%

    Propylene Glycol 0.3%

    Lubricant eye drops

    for irritated eyes

    ● Long-Lasting Protection

    ● Fast Relief

    0.3 FL OZ (10 mL)

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    LUBRICATING RELIEF 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-327
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 4 mg  in 1 mL
    Propylene Glycol (Propylene Glycol) Propylene Glycol 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Sorbitol  
    Boric Acid  
    Aminomethylpropanol  
    Hypromelloses  
    Sodium Chloride  
    Potassium Chloride  
    Hydrochloric Acid  
    Sodium Hydroxide  
    Benzalkonium Chloride  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-327-04 1 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 02/22/2013
    Labeler - Kroger Company (006999528)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(30142-327), ANALYSIS(30142-327), STERILIZE(30142-327), PACK(30142-327), LABEL(30142-327)
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