Otc - Active Ingredient
Ferric Subsulfate 20-22% by weight
Monsels Solution Paste
FDA Label NDC 48783-113
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 48783-113). 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 otc - active ingredient, inactive ingredient, storage and handling, dosage & administration, package label.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 (15-30degC)
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.
Package Label.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
* Please review the disclaimer below.
