FDA.reportPublic FDA data

Stasis Solution

Manufacturer
Gingi-Pak a Division of the Belport | Jeff Nichols
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:36:21

Label at a glance#

ProductSTASIS
Active ingredientFERRIC SULFATE
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Uses

INDICATIONS & USAGE SECTION

UsesUses

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Warning

WARNINGS SECTION

WarningsWarnings

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctorStop use and ask a doctor

Precautions

PRECAUTIONS SECTION

Precautions Temporary discoloration of tissue may occur for 24 to 48 hours. (Reassure patient that discoloration will disappear).

IT IS NOT RECOMMENDED THAT FERRIC SULFATE SOLUTIONS SUCH AS STASIS BE USED IN COMBINATION WITH EPINEPHRINE OR EPINEPHRINE IMPREGNATED RETRACTION MATERIALS BECAUSE LONG TERM AND POSSIBLE PERMANENT STAINING MIGHT OCCUR.

Stains on hands and clothing may generally be removed with the use of 3% Hydrogen Peroxide.

Storage

STORAGE AND HANDLING SECTION

StorageStorage

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Principal Display-Stasis 15 cc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display-Stasis 15 ccPrincipal Display-Stasis 15 cc

Principal Display-Stasis 40 cc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display-Stasis 40 ccPrincipal Display-Stasis 40 cc

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
10129-031-012025-01-30C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-012025-01-30C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-022025-01-30C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-022025-01-30C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-012021-09-02C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-012021-09-02C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-022021-09-02C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-022021-09-02C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-012021-07-23C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-012021-07-23C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-022021-07-23C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution
10129-031-022021-07-23C16284748780-1c7ccaba7-0e82-fd44-e053-dadaa90aa01bStasis Solution

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
10129-03110129-031-01, 10129-031-02

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 SULFATE3HWS7HF5XDACTIM
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22022-07-18full-release2026-05-31 23:50:13

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
STASISFERRIC SULFATEGingi-Pak a Division of the Belport758b87c1-886f-4316-e053-2a91aa0ac7be2026-05-01WarningsExact identifier
ndc (package): 10129-031-02
ndc (package): 10129-031-01
ndc (product): 10129-031
ndc11 (package): 10129003102
ndc11 (package): 10129003101
spl id: 50cc21f6-a0d8-b970-e063-6294a90a5c3d
spl set id: 758b87c1-886f-4316-e053-2a91aa0ac7be

Reported adverse events (FAERS/openFDA)#

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