Label: LEADER ORIGINAL EYE DROPS- tetrahydrozoline hcl solution/ drops

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 23, 2023

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  • Active ingredient

    Tetrahydrozoline HCL 0.05%

  • Purpose

    Redness reliever

  • Uses

    • relieves redness of the eye due to minor eye irritations
  • 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
    • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
    • if solution changes color or becomes cloudy, do not use
    • overuse may produce increased redness of the eye
    • remove contact lens before using

    Stop use and ask a doctor if

    you experience

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

    If pregnant or breast-feeding

    ask a health professional before use

    Keep out of reach of chlidren

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

  • Directions

    Instill 1 or 2 drops in the affected eye(s) up to four times daily

  • Other information

    store at 15-30°C (59°-86°F)

  • Inactive ingredients

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

  • Questions or comments?

    1-888-527-4276

  • Leader Original Eye Drops 15mL

    Leader Original Eye Drops 15mL

  • INGREDIENTS AND APPEARANCE
    LEADER ORIGINAL EYE DROPS 
    tetrahydrozoline hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0454
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0454-11 in 1 CARTON02/19/2019
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01802/19/2019
    Labeler - Cardinal Health (063997360)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(70000-0454) , pack(70000-0454) , label(70000-0454)
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