Label: EXCHANGE SELECT ARTIFICIAL TEARS LUBRICANT EYE DROPS- glycerin, hypromellose, polyethylene glycol 400 solution

  • NDC Code(s): 55301-178-01
  • Packager: Army and Air Force Exchange Service
  • 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

    Purpose

    Glycerin....Lubricant

    Hypromellose....Lubricant

    Polyethylene glycol 400....Lubricant

  • INDICATIONS & USAGE

    Uses

    • For 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 worsens 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 bvefore using

    Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

    If pregnant or breast feeding, ask a health professional before use

  • DOSAGE & ADMINISTRATION

    Directions

    • Instill 1 or 2 drops in the affected eye(s) as needed.
    • Children under 6 years of age: ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • RETAIN THIS CARTON FOR FUTURE REFERENCE
    • Store at 15º-30ºC (59º-86ºF)
  • INACTIVE INGREDIENT

    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
    EXCHANGE SELECT ARTIFICIAL TEARS LUBRICANT EYE DROPS 
    glycerin, hypromellose, polyethylene glycol 400 solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-178
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED0.2 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-178-011 in 1 CARTON02/12/2020
    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 DrugM01802/12/2020
    Labeler - Army and Air Force Exchange Service (001695568)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(55301-178) , pack(55301-178) , label(55301-178)
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