Label: GNP EYE DROPS DRY EYE RELIEF- glycerin, hypromellose, polyethylene glycol 400 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 July 25, 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 finalpart34908/27/2019
    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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