FDA.reportPublic FDA data

TRIBIOTIC

Manufacturer
HART Health
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:05

Label at a glance#

ProductTRIBIOTIC
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neomycin Sulfate (neomycin 3.5mg) 

Polymyxin B Sulfate (polymyxin B 5,000 units)

OTC - PURPOSE SECTION

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

INDICATIONS & USAGE SECTION

Uses: First aid to help prevent infection 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. 1-800-222-1222

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

Other Information

OTHER SAFETY INFORMATION

  • avoid excessive heat
  • ointment enclosed in a sealed packet
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)

INACTIVE INGREDIENT SECTION

White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HB 5484 Tribiotic 05gm R-b v25c - Final_SmallJpeg.jpgHB 5484 Tribiotic 05gm R-b v25c - Final_SmallJpeg.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 OintmentPSN1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY1

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

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
50332-009350332-0093-3, 50332-0093-6, 50332-0093-5

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
WHITE PETROLATUMB6E5W8RQJ4IACT

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
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthc1903b9f-390a-4756-800c-fd93be4182e32025-08-13Warnings, Adverse reactionsExact identifier
ndc (package): 50332-0093-3
ndc (package): 50332-0093-6
ndc (package): 50332-0093-5
ndc (product): 50332-0093
ndc11 (package): 50332009305
ndc11 (package): 50332009303
ndc11 (package): 50332009306
spl id: 5bad4d6f-5a06-468e-925b-a8bb26e85eb8
spl set id: c1903b9f-390a-4756-800c-fd93be4182e3

Reported adverse events (FAERS/openFDA)#

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