FDA.reportPublic FDA data

bacitracin zinc, neomycin sulfate and polymyxin b sulfate

Manufacturer
Dynarex Corporation
Effective date
2011-03-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:27:32

Label at a glance#

Productbacitracin zinc, neomycin sulfate and polymyxin b sulfate
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure10 sections

Indications and uses

First aid to help prevent infection in: Minor cuts scrapes burns

Dosage and administration

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in ea. gram)                                                Purpose           
Bacitracin Zinc 400 Units                                                                      antibacterial

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)                         antibacterial

Polymyxin B Sulfate 5000 Units                                                            antibacterial

Uses triple antibiotic :

OTC - PURPOSE SECTION

First aid to help prevent infection in:
  • Minor cuts
  • scrapes
  • burns

Ask a doctor before use:

OTC - ASK DOCTOR SECTION

  • in case of deep or puncture wounds
  • animal bites
  • serious burns

Other information

SPL UNCLASSIFIED SECTION

  • store at controlled room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat and humidity
  • Tamper Evident. Do not use if packet is torn, cut or open.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

White petrolatum

Directions triple antibiotic:

DOSAGE & ADMINISTRATION SECTION

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

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.

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic

triple_antibiotictriple_antibiotic

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 OintmentPSN3
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD3
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY3

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
67777-240-012019-10-29C16284748780-1960f7f55-cd0d-8e05-e053-dbdaa90a074aTriple Antibiotic
67777-240-022019-10-29C16284748780-1960f7f55-cd0d-8e05-e053-dbdaa90a074aTriple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-240-01bacitracin zinc, neomycin sulfate and polymyxin b sulfate12 in 1 CASEOINTMENT123
67777-240-01bacitracin zinc, neomycin sulfate and polymyxin b sulfate144 in 1 BOXOINTMENT1443
67777-240-02bacitracin zinc, neomycin sulfate and polymyxin b sulfate12 in 1 CASEOINTMENT123
67777-240-02bacitracin zinc, neomycin sulfate and polymyxin b sulfate144 in 1 BOXOINTMENT1443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-240BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]3Legacy NDC, 4 package rows20110324_650d1b78-005c-41eb-9df4-67a5d576c02b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES3
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266933
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D43
BACITRACIN ZINCACTIVE MOIETY89Y4M234ES3
NEOMYCINACTIVE MOIETYI16QD7X2973
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U3

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
67777-24067777-240-01, 67777-240-02

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
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIB
NEOMYCIN SULFATE057Y626693ACTIB
POLYMYXIN B SULFATE19371312D4ACTIB

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
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact 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
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
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
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %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
17776a1c-d279-4cdc-8860-ce18c2ceca34650d1b78-005c-41eb-9df4-67a5d576c02b2011-03-23WarningsExact identifier
spl id: 17776a1c-d279-4cdc-8860-ce18c2ceca34
spl set id: 650d1b78-005c-41eb-9df4-67a5d576c02b

Reported adverse events (FAERS/openFDA)#

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