Monsels Solution
Monsels
Approved
Approval ID
7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2023
Manufacturers
FDA
Premier Dental Products Company
DUNS: 014789663
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ferric Subsulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48783-112
Product Classification
G
Generic Name
Ferric Subsulfate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FERRIC SULFATEInactive
Code: 3HWS7HF5XD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERRIC SUBSULFATEActive
Quantity: 210 mg in 1 g
Code: 3QJ8WS6V8H
Classification: ACTIM
Drug Labeling Information
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 6/5/2014
Active Ingredients:
Ferric Subsulfate...20-22% by weight
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 6/5/2014
Other ingredients include thickeners, preservatives and purified water.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 1/5/2018
Do not reuse, discard after one use.
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 1/5/2018
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