FDA.reportPublic FDA data

BRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:46

Label at a glance#

ProductBRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4%
Active ingredientBRIMONIDINE TARTRATE, METRONIDAZOLE, NIACINAMIDE, IVERMECTIN
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934- 1028-2 BRIMONIDINE TARTRATE USP 0.25% / IVERMECTIN USP 1% / METRONIDAZOLE USP 1% / NIACINAMIDE USP 4%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BRIMONIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230503
IVERMECTIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
METRONIDAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1028-22021-01-29C16284748780-1ba0f9c33-44d9-a910-e053-dadaa90a0b85BRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1028-2BRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1028BRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190516_88f00580-a0c9-168f-e053-2a95a90a6e4b.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-102872934-1028-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRIMONIDINE TARTRATE4S9CL2DY2HACTIB
METRONIDAZOLE140QMO216EACTIB
NIACINAMIDE25X51I8RD4ACTIB
IVERMECTIN8883YP2R6DACTIB

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
88f00580-a0ca-168f-e053-2a95a90a6e4b88f00580-a0c9-168f-e053-2a95a90a6e4b2019-05-15Adverse reactionsExact identifier
spl id: 88f00580-a0ca-168f-e053-2a95a90a6e4b
spl set id: 88f00580-a0c9-168f-e053-2a95a90a6e4b

Reported adverse events (FAERS/openFDA)#

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