Label: MONSELS SOLUTION- ferric sub sulfate 20% liquid

  • 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 March 1, 2018

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  • DESCRIPTION

    Ferric Sub sulfate 20%

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

  • STORAGE AND HANDLING

    Store at (15-30C)

  • HOW SUPPLIED

    Contents 12 single application vials
    12 rayon tip applicators

  • INDICATIONS & USAGE

    Used as a styptic in its undiluted form.

  • PRECAUTIONS

    To be used by a lic. Medical practitioner only.

    Uni dose. Discard after single use.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MONSELS SOLUTION 
    ferric sub sulfate 20% liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42721-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42721-112-0812 in 1 BOX08/26/2014
    18 g in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/26/2014
    Labeler - BIODIAGNOSTIC INTERNATIONAL (107716672)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Bio Diagnostic068328873manufacture(42721-112)