Label: MONSELS SOLUTION- ferric subsulfate paste

  • 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 October 25, 2021

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  • Active Ingredients:

    Ferric Subsulfate...20-22% by weight

  • INACTIVE INGREDIENT

    Other ingredients include thickeners, preservatives and purified water.

  • DOSAGE & ADMINISTRATION

    Restricted to use by or on the order of a licensed healthcare professional.

    Single-Use only. Do not reuse, discard after one use.

  • STORAGE AND HANDLING

    Keep cap tightly sealed and away from light.

    Store at room temperature (15-30°C).

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    MONSELS SOLUTION 
    ferric subsulfate paste
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48992-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION210 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC SULFATE (UNII: 3HWS7HF5XD)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48992-001-0114 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product03/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/13/2020
    Labeler - Gynex Corporation (012997685)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diversified Chemical Products, Inc.030317424manufacture(48992-001)