Monsels Solution

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.

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.

8ml label
(click image for full-size original)
MONSELS SOLUTION
ferric subsulfate paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48783-112
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC SUBSULFATE (FERRIC CATION) FERRIC CATION 210 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FERRIC SULFATE
SODIUM BENZOATE
WATER
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48783-112-08 14 g in 1 VIAL, SINGLE-DOSE None
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)

Revised: 12/2019 Premier Dental Products Company

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