MONSELS SOLUTION- ferric subsulfate paste 
Gynex Corporation

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.

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Active Ingredients:

Ferric Subsulfate...20-22% by weight

Other ingredients include thickeners, preservatives and purified water.

Restricted to use by or on the order of a licensed healthcare professional.

Single-Use only. Do not reuse, discard after one use.

Keep cap tightly sealed and away from light.

Store at room temperature (15-30°C).

PRINCIPAL DISPLAY PANEL

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MONSELS SOLUTION 
ferric subsulfate paste
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48992-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION210 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC SULFATE (UNII: 3HWS7HF5XD)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48992-001-0114 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product03/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/13/2020
Labeler - Gynex Corporation (012997685)
Establishment
NameAddressID/FEIBusiness Operations
Diversified Chemical Products, Inc.030317424manufacture(48992-001)

Revised: 10/2021
Document Id: cf32cbad-332c-2546-e053-2a95a90a5b30
Set id: 170ce265-2951-47a6-8f56-a27cc39cbdf8
Version: 2
Effective Time: 20211025
 
Gynex Corporation