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

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 21, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • Gynex Label

    Contains 8ml NDC 48783-112-08

    Gynex

    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. GynexLabel

  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!