FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
B8 Sales, Inc.
Effective date
2010-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:21

Label at a glance#

ProductTriple Antibiotic
Active ingredientBacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Label structure10 sections

Indications and uses

First aid to help prevent infection in minor cuts, scrapes and burns

Dosage and administration

clean the affected area apply a 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 dally may be covered with a sterile bandage consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Triple Antibiotic Ointment™

First Aid to Help Prevent Infection In Minor Cuts, Scrapes, and Burns

25 Packets

Each Packet Net.Wt.0.9gm

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitradn Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg Neomycin base)

Polymyxin-B Sulfate 5000 units

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • internally
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Stop use and ask a doctor If

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

Keep out reach of children. If swallowed, get

medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over:

SPL UNCLASSIFIED SECTION

  • clean the affected area
  • apply a 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 dally
  • may be covered with a sterile bandage

Children under 2 years:

SPL UNCLASSIFIED SECTION

  • consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum

Triple Antibiotic Ointment™

Manufactured for:

B8 SALES

Cincinnati,0hio 4521S

888-826-6208

www.b8sales.com

PIO Put it on®

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment – Carton Label

PIO Put it on®

Triple Antibiotic Ointment™

First Aid to Help Prevent Infection In Minor Cuts, Scrapes, and Burns

25 Packets

Each Packet Net.Wt.0.9gm

Triple Antibiotic Ointment – Carton Label
Triple Antibiotic Ointment – Carton Label

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
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50607-5600-12020-01-31C16284748780-19d75b9d0-daf8-f424-e053-dadaa90a57cePIO Put it on®
50607-5600-22020-01-31C16284748780-19d75b9d0-daf8-f424-e053-dadaa90a57cePIO Put it on®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50607-5600-1Triple Antibiotic.9 g in 1 POUCHOINTMENT.91
50607-5600-1Triple Antibiotic25 in 1 BOXOINTMENT251
50607-5600-2Triple Antibiotic144 in 1 BOXOINTMENT1441
50607-5600-2Triple Antibiotic.9 g in 1 POUCHOINTMENT.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50607-5600TRIPLE ANTIBIOTIC OINTMENT [B8 SALES, INC.]1Legacy NDC, 4 package rows20100501_93611650-ec45-4b83-872e-b1e227bdec11.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ES1
Neomycin SulfateACTIVE INGREDIENT057Y6266931
Polymyxin B SulfateACTIVE INGREDIENT19371312D41
Bacitracin ZincACTIVE MOIETY89Y4M234ES1
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 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50607-560050607-5600-1, 50607-5600-2

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
Bacitracin Zinc89Y4M234ESACTIB
Neomycin Sulfate057Y626693ACTIB
Polymyxin B Sulfate19371312D4ACTIB
petrolatum4T6H12BN9UIACT

Source Document#

Source XML

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 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
51d351ee-2de5-45f1-a1c2-e1b05433a30093611650-ec45-4b83-872e-b1e227bdec112010-04-02WarningsExact identifier
spl id: 51d351ee-2de5-45f1-a1c2-e1b05433a300
spl set id: 93611650-ec45-4b83-872e-b1e227bdec11

Reported adverse events (FAERS/openFDA)#

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