DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL) LIQUID [MCKESSON CORPORATION]

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DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL) LIQUID [MCKESSON CORPORATION]
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NDC 62011-0196-1
Set ID 5ba9c3e3-e5b9-4bdd-ba08-d1fa3e65c089
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class
Product Number
Application Number PART349
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  • ​Active ingredients

    Glycerin 0.2%

    Hypromellose 0.2%

    Polyethylene glycol 1%

  • ​Purpose

    Glycerin.....Lubricant

    Hypromellose.....Lubricant

    Polyethylene glycol 400.....Lubricant

  • ​Uses

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

    ​Warnings

    For external use only

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

    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 worsen or persists for more than 72 hours

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using. Keep container tightly closed
    • remove contact lens before using

    Keep out of reach of children

    If accidentally swallowed get medical help or contact a Poison Control Center immediately

    If pregnant and breast-feeding, ask a health professional before use

  • Directions

    • Instill 1 or 2 drops in the affected eye(s) as needed
    • Children under 6 years of age, ask doctor
  • Other information

    RETAIN THIS CARTON FOR FUTURE REFERENCE

    Store at 15 oC-30 oC (59 o-88 oF)

  • ​Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DRY EYE RELIEF 
    glycerin, hypromellose, polyethylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0196
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSES0.2 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.2 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
    DEXTROSE (UNII: IY9XDZ35W2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0196-11 in 1 CARTON05/01/2013
    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 finalpart34905/01/2013
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(62011-0196) , pack(62011-0196) , label(62011-0196)
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