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Monsels Solution
ferric subsulfate · Monsels Solution is a prescription drug containing ferric subsulfate, made by Premier Dental Products Company.
- Type
- Prescription
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
Drug facts
- Generic name
- ferric subsulfate
- Active ingredients
- Ferric Subsulfate
- Dosage forms
- Paste
- Label holder
- Premier Dental Products Company
- Label updated
- 01/13/2026
Active ingredients
Ferric Subsulfate 20-22% by weight
Dosage and administration
Do not reuse, discard after one use.
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
Inactive ingredients
Other Ingredients include thickeners, preservatives, and purified water
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Paste | 210 mg/g | topical | 2 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 24 reports that list ferric subsulfate, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Pain6
- Muscle spasms4
- Application site pain3
- Dysuria3
- Application site burn2
- Application site vesicles2
- Asthenia2
- Blister2
- Burning sensation2
- Chemical burn2
To report a side effect, use FDA MedWatch.
Manufacturers and labels
2 FDA labels
- Premier Dental Products CompanyShown hereLabel 01/13/2026 · NDC 48783-113Full label
- Premier Dental Products CompanyLabel 01/13/2026 · NDC 48783-112Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIIDrugOngoing04/29/2026Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical...Premier Dental Products Co · Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration...
- Class IIDrug08/30/2023AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical...Ecometics, Inc. · CGMP Deviations: Products not manufactured under current good...
- Class IIDrug07/31/2019MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with...Dercher Enterprises, Inc., DBA Gordon Laboratories · Microbial Contamination of Non-Sterile Products and Superpotent...
- Class IIDrug12/26/2018Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with...Gordon Laboratories · Superpotent Drug: contains higher levels of Iron than labeled.
- Class IIDrug07/18/2018Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8...Medgyn Products, Inc. · CGMP Deviations: The manufacturer of this product recalled because...
Monsels Solution: common questions
- Is Monsels Solution a prescription drug?
- Yes. Monsels Solution is a prescription (Rx) drug.
- Who makes Monsels Solution?
- Premier Dental Products Company lists Monsels Solution with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/13/2026 · Label text is shown as published by the manufacturer. Not medical advice