Label: GNP EYE DROPS DRY EYE RELIEF- glycerin, hypromellose, polyethylene glycol 400 solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Glycerin .....0.2%

    Hypromellose.....0.2%

    Polyethylene glycol 400.....1%

  • PURPOSE

    Purposes

    Glycerin.....Lubricant

    Hypromellose.....Lubricant

    Polyethylene glycol 400.....Lubricant

  • INDICATIONS & USAGE

    Uses

    • for protection against further irritation
    • for temporary relief of burning and irritation due to dryness of the eye
  • WARNINGS

    Warnings

    For external use only

    Do not use this product if solution changes color or becomes cloudy

    When using this product

    • to avoid contamination
    • do not touch tip of container to any surface. Replace cap after usine
    • remove contact lenses 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 (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Instill 1 to 2 drops in the affected eye(s) as needed

  • OTHER SAFETY INFORMATION

    Other informatioon

    store at 15º-30ºC (59º-86ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

  • QUESTIONS

    Questions or comments?

    Call 1-800-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    GNP EYE DROPS DRY EYE RELIEF 
    glycerin, hypromellose, polyethylene glycol 400 solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-605
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.2 g  in 100 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES0.2 g  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-605-051 in 1 CARTON08/27/2019
    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 DrugM01808/27/2019
    Labeler - AmerisourceBergen (007914906)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(46122-605) , pack(46122-605) , label(46122-605)
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