MONSELS SOLUTION- ferric subsulfate paste

Monsels Solution by

Drug Labeling and Warnings

Monsels Solution by is a Prescription medication manufactured, distributed, or labeled by Gynex Corporation, Diversified Chemical Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MONSELS SOLUTION 
ferric subsulfate paste

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 48992-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	210 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC SULFATE (UNII: 3HWS7HF5XD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48992-001-01	14 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product	03/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/13/2020

Labeler - Gynex Corporation (012997685)

Establishment
Name	Address	ID/FEI	Business Operations
Diversified Chemical Products, Inc.		030317424	manufacture(48992-001)