FDA.reportPublic FDA data

MONSELS SOLUTION

Manufacturer
Gordon Laboratories
Effective date
2011-12-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:13:26

Label at a glance#

ProductMONSELS SOLUTION
Active ingredientFERRIC SUBSULFATE
Label structure5 sections

Label contents#

Full prescribing information#

HOW SUPPLIED SECTION

Light-resistant 2 ml  bottles.

INDICATIONS & USAGE SECTION

Used as a styptic in its undiluted form.

WARNINGS AND PRECAUTIONS SECTION

It should not be used in vesicular, bullous, or exudative (oozing) dermatoses because it may then cause permanent pigmentation on the  skin.  May be harmful  if swallowed. For  external use only.  If  swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately. Keep out of reach of children. 

SPL UNCLASSIFIED SECTION

Restricted to use by or on the order of a licensed Physician. Store at room temperature. Keep cap tightly sealed and protect from light.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of MONSELS LabelsImage of MONSELS Labels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831162Monsel's ferric subsulfate 20 % - 22 % Topical SolutionPSN2
831162ferric subsulfate solution 220 MG/ML Topical SolutionSCD2
831162Monsel's 20 % - 22 % Topical SolutionSY2
831162Monsel's 20 % Topical SolutionSY2
831162Monsel's 22 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10481-0112-22019-11-13C16284748780-197449f38-bc30-f6ea-e053-dbdaa90aa703MONSELS SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10481-0112-2MONSELS SOLUTION59 g in 1 BOTTLE, GLASSLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10481-0112MONSELS SOLUTION (FERRIC SUBSULFATE) LIQUID [GORDON LABORATORIES]2Legacy NDC, 1 package rows20111208_88c340cc-c7fc-4423-ac3b-f80536acafb8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10481-0112-2ML - Milliliter10481-01126ea49832-1322-4e62-9765-34f9a622af3012013-03-03
10481-0112-8ML - Milliliter10481-0112ca318f04-4e3c-4ffa-974c-46e434e2ab2512013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRIC SUBSULFATEACTIVE INGREDIENT3QJ8WS6V8H2
FERRIC SUBSULFATEACTIVE MOIETY3QJ8WS6V8H2

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10481-011210481-0112-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
FERRIC SUBSULFATE3QJ8WS6V8HACTIB

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
49a2555d-073f-4c02-8dc1-fdd42396cad488c340cc-c7fc-4423-ac3b-f80536acafb82011-12-07WarningsExact identifier
spl id: 49a2555d-073f-4c02-8dc1-fdd42396cad4
spl set id: 88c340cc-c7fc-4423-ac3b-f80536acafb8

Reported adverse events (FAERS/openFDA)#

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