Label: RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION- tetrahydrozoline hcl solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • Active Ingredient

    Tetrahydrozoline HCI 0.05%

  • Purpose

    Redness Reliever

  • Use

    relieves redness in eye due to minor eye irritations

  • Warnings

    For external use only

    Warnings

    Ask a doctor before use if you have narrow angle glaucoma

    Warnings

    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

    Warnings

    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

    Warnings

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

    Warnings

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

  • Directions

    instill 1 to 2 drops in the affected eye(s) up to 4 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?

    1-800-645-2158

  • Rugby Tetrahydrozoline Ophthalmic Solution

    Rugby Tetrahydrozoline Ophthalmic Solution

  • INGREDIENTS AND APPEARANCE
    RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION 
    tetrahydrozoline hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1217
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1217-941 in 1 BOX06/08/2019
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01806/08/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(0536-1217) , pack(0536-1217) , label(0536-1217)
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