FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
ProStat First Aid | Safetec of America, Inc.
Effective date
2013-09-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:36

Label at a glance#

ProductTriple Antibiotic
Active ingredientbacitracin zinc, neomycin sulfate, polymyxin b sulfate
Label structure12 sections

Indications and uses

first aid to help prevent infection in: minor cuts scrapes 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 daily may be covered with a sterile bandage

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (each gram contains)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 400 units

Neomycin sulfate 5 mg
(equivalent to 3.5 mg of 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
  • burns

Warnings

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition worsens
  • a rash or other allergic reaction develops

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.

Directions

DOSAGE & ADMINISTRATION 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 daily
  • may be covered with a sterile bandage

Other Information

SPL UNCLASSIFIED SECTION

  • store at 15°-25°C (59°-77°F)
  • tamper evident sealed packets
  • do not use packet if opened or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum

Questions?

OTC - QUESTIONS SECTION

888.900.2920

prostatfa.com

PRINCIPAL DISPLAY PANEL – ProStat 25 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROSTAT
FIRST AID

Part No. #2009

Triple Antibiotic
Bacitracin, Neomycin, Polymyxin

Ungüento Triple Antibiotico
Bacitracina, neomicina, polimixina

25 pcs Unit Dose • 0.5g - (1/55 oz) each

PRINCIPAL DISPLAY PANEL – ProStat 25 count box
PRINCIPAL DISPLAY PANEL – ProStat 25 count box

PRINCIPAL DISPLAY PANEL – Front Line 25 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRONT LINE

Triple Antibiotic
Bacitracin, Neomycin, Polymyxin

Ungüento Triple Antibiotico
Bacitracina, neomicina, polimixina

25 pcs Unit Dose • 0.5g - (1/55 oz) each

PRINCIPAL DISPLAY PANEL – Front Line 25 count box
PRINCIPAL DISPLAY PANEL – Front Line 25 count box

PRINCIPAL DISPLAY PANEL – packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROSTAT
FIRST AID

Triple Antibiotic

0.5 g (1/57oz)

Distributed by:
ProStat First Aid LLC,
Valencia, CA 91355

PRINCIPAL DISPLAY PANEL – packet
PRINCIPAL DISPLAY PANEL – packet

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 OintmentPSN2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2

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
58228-5600-12021-01-29C16284748780-1ba0f9c33-216e-a910-e053-dadaa90a0b85f588bd1b-6087-453a-b268-e1ec4241c37e
58228-5600-22021-01-29C16284748780-1ba0f9c33-216e-a910-e053-dadaa90a0b85f588bd1b-6087-453a-b268-e1ec4241c37e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-5600-0Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52
58228-5600-1Triple Antibiotic25 in 1 BOXOINTMENT252
58228-5600-2Triple Antibiotic25 in 1 BOXOINTMENT252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-5600TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [PROSTAT FIRST AID]2Legacy NDC, 3 package rows20191231_f588bd1b-6087-453a-b268-e1ec4241c37e.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
58228-560058228-5600-0, 58228-5600-1, 58228-5600-2

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 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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %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
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %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
c821dacb-ebf6-4a85-a292-9be07c3a6377f588bd1b-6087-453a-b268-e1ec4241c37e2013-09-20WarningsExact identifier
spl id: c821dacb-ebf6-4a85-a292-9be07c3a6377
spl set id: f588bd1b-6087-453a-b268-e1ec4241c37e

Reported adverse events (FAERS/openFDA)#

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