FDA.reportPublic FDA data

Monsels Solution

Manufacturer
MedGyn Products, Inc.
Effective date
2016-07-29
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:22:33

Label at a glance#

ProductMonsels Solution
Active ingredientFERRIC SUBSULFATE
Label structure6 sections

Storage and handling

Store at room temperature(15°-30°C). Keep away from heat and light.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Ferric Subsulfate 20%

STORAGE AND HANDLING SECTION

Store at room temperature(15°-30°C). Keep away from heat and light.

INDICATIONS & USAGE SECTION

Hemostasis of small cuts and biopsies

PRECAUTIONS SECTION

To be used by a licensed medical practitioner only. Unit dose. Discard after single use.

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:

MedGyn Products, Inc

100 W. Industrial Rd.

Addison,IL 60101 USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831162Monsel's ferric subsulfate 20 % - 22 % Topical SolutionPSN1
831162ferric subsulfate solution 220 MG/ML Topical SolutionSCD1
831162Monsel's 20 % - 22 % Topical SolutionSY1
831162Monsel's 20 % Topical SolutionSY1
831162Monsel's 22 % Topical SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FERRIC CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70880-112-082020-01-31C16284748780-19d75b9d0-41c5-f424-e053-dadaa90a57ceMonsel's Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70880-112-08Monsels Solution12 in 1 BOXSOLUTION121
70880-112-08Monsels Solution8 mL in 1 BOTTLESOLUTION81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70880-112MONSELS SOLUTION (FERRIC SUBSULFATE) SOLUTION [MEDGYN PRODUCTS, INC.]1Legacy NDC, 2 package rows20160802_38246578-f9cc-4e86-b65d-341eebcef1cc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70880-11270880-112-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC SUBSULFATE3QJ8WS6V8HACTIM
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
489301eb-95b6-468e-a00f-5a92189cb5f438246578-f9cc-4e86-b65d-341eebcef1cc2016-07-29Exact identifier
spl id: 489301eb-95b6-468e-a00f-5a92189cb5f4
spl set id: 38246578-f9cc-4e86-b65d-341eebcef1cc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.