FDA.reportPublic FDA data

TRIBIOTIC

Manufacturer
HART Health
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:07:35

Label at a glance#

ProductTRIBIOTIC
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

Polymyxin B Sulfate 5,000 units

OTC - PURPOSE SECTION

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

INDICATIONS & USAGE SECTION

Uses: First aid to help prevent infection and temporarily relieve pain in

  • minor cuts
  • scrapes
  • burns
  • abrasions

WARNINGS SECTION

Warnings: For external use only

Serious burns require immediate medical attention

ADVERSE REACTIONS SECTION

Allergy alert: Do not use if you are allergic to any of the ingredients

OTC - DO NOT USE SECTION

do not use

  • in or near the eyes
  • over large portions of the body
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or lasts for more than 7 days
  • a rash or other allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

Do not use more than directed.

Adults and children 12 years of age and over:

  • clean the affected area
  • apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0321Tribiotic9v23f.jpg0321Tribiotic9v23f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN5
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0032-12022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-22022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-32022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-42022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-52022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-62022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-12021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-22021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-32021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-42021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-52021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-62021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0032TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]5Current NDC, Legacy NDC20240119_d8f175f9-f526-4c73-a171-49309ca16cb0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266931
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D41
BACITRACINACTIVE MOIETY58H6RWO52I1
NEOMYCINACTIVE MOIETYI16QD7X2971
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-003250332-0032-6, 50332-0032-3, 50332-0032-5, 50332-0032-1, 50332-0032-2, 50332-0032-4

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
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates

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
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
ndc (package): 50332-0032-5
ndc (package): 50332-0032-2
ndc (package): 50332-0032-3
ndc (package): 50332-0032-6
ndc (package): 50332-0032-1
ndc (package): 50332-0032-4
ndc (product): 50332-0032
ndc11 (package): 50332003203
ndc11 (package): 50332003201
ndc11 (package): 50332003204
ndc11 (package): 50332003206
ndc11 (package): 50332003202
ndc11 (package): 50332003205
spl id: 9bdb3479-2b97-45d5-a82e-a5db1c149595
spl set id: d8f175f9-f526-4c73-a171-49309ca16cb0

Reported adverse events (FAERS/openFDA)#

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