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OptiClear (Major Pharmaceuticals)

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SOLUTION/ DROPS 15 mL in 1 BOTTLE (0904-2992-35) Label Information

Complete OptiClear Information

  • Active ingredient

    Tetrahydrozoline HCl 0.05%


  • Purpose

    Redness Reliever


  • Uses

    • relieves redness of the eye due to minor eye irritations

  • Warnings

    Do not use if solution changes color or becomes cloudy

    Ask a doctor before use if you have
    narrow angle glaucoma

    When using this product  

    • do not touch tip of container to any surface to avoid contamination
    • overuse may produce increased redness of the eye
    • pupils may become enlarged temporarily

    Stop use and ask a doctor if

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

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away


  • Directions

    • instill 1 to 2 drops in the affected eye(s) up to four times daily or as directed by a doctor

  • Other information

    • store at 15° - 30°C (59° - 86°F)
    • keep tightly closed
    • replace cap after use

  • Inactive ingredients

    boric acid, edetate disodium, sodium borate, sodium chloride, purified water.

    Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

    PRESERVATIVE ADDED: benzalkonium chloride 0.01%


  • Questions or comments?

    Serious side effects associated with use of this product may be reported to 1800-323-0000


  • Package/Label Principal Display Panel

    Carton

    NDC 0904-2992-35

    MAJOR®

    STERILE

    OPTI-CLEAR

    Tetrahydrozoline Hydrochloride Ophthalmic Solution, USP

    Redness Reliever Eye Drops

    For minor eye irritations

    1/2 fl oz (15 mL)

    Compared to active ingredient of Visine®* Original


  • INGREDIENTS AND APPEARANCE
    OPTICLEAR 
    tetrahydrozoline hcl solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-2992
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-2992-35 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 10/07/2011
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 807927397 MANUFACTURE