Label: COLIRIO OCUSAN- tetrahydrozoline hydrochloride, polyethylene glycol 400, povidone, unspecified, and dextran 70 liquid

  • NDC Code(s): 24286-1575-1
  • 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
    Dextran 70 0.1%Lubricant
    Polyethylene Glycol 400 1%Lubricant
    Povidone 1%Lubricant
    Tetrahydrozoline HCl 0.05%Redness reliever
  • Use

    • for the relief of redness of the eye due to minor eye irritations
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

    Ask a doctor before use if you have narrow angle glaucoma.

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • 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 lasts
    • condition worsens or lasts more than 72 hours

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • Other information

    • store at 15° to 25°C (59° to 77°F)
  • Inactive ingredients

    benzalkonium chloride, boric acid, disodium edetate hydrate, sodium borate, sodium chloride, 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

    Improved Formula!

    Now
    with
    3
    Moisturizers

    Maximum
    Strength

    Colirio
    Ocusan ®

    Fast Redness Relief
    Soothes & Lubricates

    Redness Reliever /
    Lubricant Eye Drops

    STERILE

    1/2 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    COLIRIO OCUSAN 
    tetrahydrozoline hydrochloride, polyethylene glycol 400, povidone, unspecified, and dextran 70 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1575
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ, POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED10 mg  in 1 mL
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1575-11 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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