MONSELS SOLUTION- ferric subsulfate paste

Monsels Solution by

Drug Labeling and Warnings

Monsels Solution by is a Prescription medication manufactured, distributed, or labeled by Premier Dental Products Company, 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

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.

INGREDIENTS AND APPEARANCE

MONSELS SOLUTION 
ferric subsulfate paste

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 48783-112
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)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48783-112-08	14 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product	06/10/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/10/2014

Labeler - Premier Dental Products Company (014789663)