Label: MONSELS SOLUTION- ferric subsulfate paste

  • NDC Code(s): 48783-112-08
  • Packager: Premier Dental Products Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated October 24, 2024

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  • Active Ingredients:

    Ferric Subsulfate...20-22% by weight

  • INACTIVE INGREDIENT

    Other ingredients include thickeners, preservatives and purified water.

  • DOSAGE & ADMINISTRATION

    Do not reuse, discard after one use.

  • STORAGE AND HANDLING

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

    Keep cap tightly sealed.

    Protect from light.

    Mfg. for and Dist. by:

    Premier Medical Products

    Plymouth Meeting, PA 19462

  • PRINCIPAL DISPLAY PANEL

    Contains 8ml NDC 48783-112-08

    Premier

    Monsel's Ferric Subsulfate Solution

    REF 9045055

    12 single application 8ml bottles of Monsel's soution

    and 12 rayon tip applicators

    Rx ONLY Made in U.S.A. PremierMonsels

  • INGREDIENTS AND APPEARANCE
    MONSELS SOLUTION 
    ferric subsulfate paste
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48783-112
    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)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48783-112-0814 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product06/10/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/10/2014
    Labeler - Premier Dental Products Company (014789663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diversified Chemical Products Inc030317424manufacture(48783-112)
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