Active Ingredients:
Ferric Subsulfate...20-22% by weight
Monsels Solution Paste
FDA Label NDC 48783-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Premier Dental Products Company for the product Monsels Solution (NDC 48783-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, inactive ingredient, storage and handling, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Other ingredients include thickeners, preservatives and purified water.
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.
8ml Label (Label)
* Please review the disclaimer below.
