Label: OPTICAL ORIGINAL EYE DROPS- tetrahydrozoline hydrochloride solution

  • 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 October 31, 2012

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  • ACTIVE INGREDIENT

    Active ingredient                                                           Purpose

    Tetrahydrozoline HCL 0.05%.........................................Redness reliever

  • PURPOSE

    Uses

    • for the relief of redness of the eyes due to minor eye irritations
  • WARNINGS

    Warnings

    Ask a doctor before use if you have narrow angle glaucoma

  • WHEN USING

    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
    • to avoid contamination, do not touch tip
    • replace cap after each use
  • STOP 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    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
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • store at 15o to 25oC (59o to 77oF)
  • INACTIVE INGREDIENT

    Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

  • DOSAGE & ADMINISTRATION

    Distributed by

    Televisa Consumer Products USA, LLC

    4550 Post Oak Place Suite 326

    Houston, TX 77027

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    OPTICAL ORIGINAL EYE DROPS  
    tetrahydrozoline hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55038-023
    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
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55038-023-151 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/31/2012
    Labeler - TELEVISA CONSUMER PRODUCTS USA (840246230)
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