Label: GNP EYE DROPS SEASONAL RELIEF- tetrahydrozoline hcl, zinc sulfate solution

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

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Tetrahydrozoline HCl....0.05%

    Zinc sulfate.....0.25%

  • PURPOSE

    Purposes

    Tetrahydrozoline HCl......Redness reliever

    Zinc sulfate......Astringent

  • INDICATIONS & USAGE

    Use

    • for temporary relief of discomfort and redness of the eye due to minor eye irritation
  • WARNINGS

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

  • DOSAGE & ADMINISTRATION

    Directions

    Instill 1 to 2 drops in the affected eye(s) up to 4 times daily.

  • OTHER SAFETY INFORMATION

    Other information

    store at 15º-30ºC (59º-86ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments?

    Call 1-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    GNP EYE DROPS SEASONAL RELIEF 
    tetrahydrozoline hcl, zinc sulfate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-602
    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
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-602-051 in 1 CARTON08/28/2019
    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 DrugM01808/28/2019
    Labeler - AmerisourceBergen (007914906)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(46122-602) , pack(46122-602) , label(46122-602)
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