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
  • 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 February 13, 2020

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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
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    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 finalpart34902/12/2020
    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)