MONSELS SOLUTION- ferric subsulfate paste 
Premier Dental Products Company

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.

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Monsels

Active Ingredients:

Ferric Subsulfate...20-22% by weight

Other ingredients include thickeners, preservatives and purified water.

Do not reuse, discard after one use.

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

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)

Revised: 1/2026
Document Id: 4847c0c4-f60a-2f71-e063-6294a90a5830
Set id: 7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db
Version: 8
Effective Time: 20260113
 
Premier Dental Products Company