GYNEX MONSELS SOLUTION- ferric subsulfate paste

Gynex Monsels Solution by

Drug Labeling and Warnings

Gynex 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 INGREDIENT

Ferric Subsulfate 20-22% by weight

INACTIVE INGREDIENT

Other Ingredients include thickeners, preservatives, and purified water

STORAGE AND HANDLING

Store at room temperature (15-30degC)

Keep cap tightly sealed

Protect from light

Mfg. for and distrib. by:

Gynex

North Richland Hills, TX

DOSAGE & ADMINISTRATION

Do not reuse, discard after one use.

PRINCIPAL DISPLAY PANEL

NDC: 48783-113-08

Gynex Monsel's Ferric Subsulfate Paste

REF 5055

Monsel's Ferric Subsulfate Paste 20-22%, Non-Sterile, Single-Patient Use

12 single applications - 8mL vials, 12 rayon-tipped applicators

INGREDIENTS AND APPEARANCE

GYNEX MONSELS SOLUTION 
ferric subsulfate paste

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 48783-113
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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FERRIC SULFATE (UNII: 3HWS7HF5XD)
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: 48783-113-08	14 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product	11/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/29/2024

Labeler - Premier Dental Products Company (014789663)

Establishment
Name	Address	ID/FEI	Business Operations
Diversified Chemical Products Inc		030317424	manufacture(48783-113)