FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
Provision Medical | Safetec of America, Inc.
Effective date
2014-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:08

Label at a glance#

ProductTriple Antibiotic
Active ingredientbacitracin zinc, neomycin sulfate, polymyxin b sulfate
Label structure7 sections

Dosage and administration

clean affected area apply a small amount 1 to 3 times daily may cover with a sterile bandage

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each gram)

Bacitracin zinc (400 units bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Use

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 eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • a rash or allergic reaction develops
  • condition worsens or persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum

Principal Display Panel - 0.5g Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

ointment

Helps Prevent Infection in Cuts and Scrapes

TRIPLE ANTIBIOTIC

0.5g

The Provision First Aid LineTM

Principal Display Panel - 0.5g Packet Label
Principal Display Panel - 0.5g Packet 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
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
69103-5005-12020-01-31C16284748780-19d75b9d0-4759-f424-e053-dadaa90a57ce1cfd7b7b-a661-4889-b2a6-ab3ecf18f1f8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69103-5005-1Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69103-5005TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [PROVISION MEDICAL]1Legacy NDC, 1 package rows20140904_1cfd7b7b-a661-4889-b2a6-ab3ecf18f1f8.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
69103-500569103-5005-1

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

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
petrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact 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
2a1ca9f4-e0b9-4540-bb99-091ad0404e171cfd7b7b-a661-4889-b2a6-ab3ecf18f1f82014-08-29WarningsExact identifier
spl id: 2a1ca9f4-e0b9-4540-bb99-091ad0404e17
spl set id: 1cfd7b7b-a661-4889-b2a6-ab3ecf18f1f8

Reported adverse events (FAERS/openFDA)#

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