FDA Label for Monsels Solution
View Indications, Usage & Precautions
Monsels Solution Product Label
The following document was submitted to the FDA by the labeler of this product Premier Dental Products Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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.
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
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