Label: MONSELS SOLUTION- ferric subsulfate solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 29, 2016

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  • DESCRIPTION

    Ferric Subsulfate 20%

  • STORAGE AND HANDLING

    Store at room temperature(15°-30°C). Keep away from heat and light.

  • INDICATIONS & USAGE

    Hemostasis of small cuts and biopsies

  • PRECAUTIONS

    To be used by a licensed medical practitioner only. Unit dose. Discard after single use.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:

    MedGyn Products, Inc

    100 W. Industrial Rd.

    Addison,IL 60101 USA

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MONSELS SOLUTION 
    ferric subsulfate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70880-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70880-112-0812 in 1 BOX08/01/2016
    18 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2016
    Labeler - MedGyn Products, Inc. (103913430)