Label: OCUSAN DRY EYES- polyethylene glycol 400, propylene glycol liquid

  • NDC Code(s): 24286-1292-5
  • Packager: DLC 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 January 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Polyethylene Glycol 400 0.4%Lubricant
    Proplyene Glycol 0.3%Lubricant
  • Use

    • 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 ingredients 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 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 to 2 drops in the affected eye(s) as needed
  • Other information

    • store at room temperature
  • Inactive ingredients

    benzalkonium chloride, boric acid, hydrochloric acid, hypromellose, potassium chloride, sodium chloride, sodium hydroxide, water for injection

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    DLC LABORATORIES, INC.
    PARAMOUNT, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box

    Advanced Formula!

    Fase Acting


    Ocusan ®

    Dry Eyes

    Moisturizes & Soothes Dry Eyes



    Lubricant Eye Drops / Relieves Buring and Irritation

    STERILE

    1/2 FL OZ (15 mL)

    carton

  • INGREDIENTS AND APPEARANCE
    OCUSAN DRY EYES 
    polyethylene glycol 400, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1292
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ, POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1292-51 in 1 BOX12/16/2019
    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 finalpart34912/16/2019
    Labeler - DLC Laboratories, Inc. (093351930)
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