Label: LUBRICANT EYE DROPS SOLUTION- polyethylene glycol 400 and propylene glycol solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • ACTIVE INGREDIENT

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

    • For the temporary relief of burning, irritation and discomfort due to dryness of the eye and exposure to wind or sun.
    • May be used as a protectant against further irritation.
  • Warnings

    For use in the eyes only

  • Do not use

    • If solution changes color or becomes cloudy.
  • When using this product

    • avoid contamination, do not touch tip of container to any surface
    • replace cap after use
  • STOP USE

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • the condition worsens or persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • Directions

    • shake well before use
    • instill 1 or 2 drops in the affected eye(s) as needed
  • Other Information

    • store at room temperature 15°- 30°C (59°-86°F).
    • do not use if imprinted seal on cap is torn, broken or missing
    • discard 90 days after opening
    • retain outer carton for full product information
  • Inactive Ingredients:

    Benzalkonium chloride (preservative), boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions?

    1-855-361-3993

    Distributed by:

    AvKARE

    Pulaski, TN 38478

    www.avkare.com

    Rev. 12/2022 AV 12/2022

  • PRINCIPAL DISPLAY PANEL

    15

  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE DROPS SOLUTION 
    polyethylene glycol 400 and propylene glycol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-126
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-126-151 in 1 CARTON02/25/2003
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01802/25/2003
    Labeler - AvPAK (832926666)
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