Label: SYSFOL EYE DROPS- polyethylene glycol 400, propylene glycol liquid

  • NDC Code(s): 73669-013-01, 73669-013-02
  • Packager: Unimed Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 10, 2023

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  • ACTIVE INGREDIENT

    Polyethylene Glycol 400, Propylene Glycol

  • INACTIVE INGREDIENT

    boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium, hydroxide

  • PURPOSE

    for use as a protectant against further irritation or to relieve dryness of the eye

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Instill 1 or 2 drops in the affectd eye(s) as needed

  • WARNINGS

    For external use only
    When using this product
    ■ do not touch tip of container to any surface to avoid contamination
    ■ replace cap after each use

    ■ avoid direct sunlight

  • DOSAGE & ADMINISTRATION

    external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SYSFOL EYE DROPS 
    polyethylene glycol 400, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73669-013
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73669-013-0230 in 1 BOX04/20/2023
    1NDC:73669-013-010.4 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/20/2023
    Labeler - Unimed Pharmaceuticals, Inc. (689852052)
    Registrant - Unimed Pharmaceuticals, Inc. (689852052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed Pharmaceuticals, Inc.689852052label(73669-013) , manufacture(73669-013) , pack(73669-013)
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