FDA.reportPublic FDA data

Poly Bacitracin

Manufacturer
Phoenix Global Supply Group, Inc | Axellia Pharmaceuticals AS | Axellia Pharmaceuticals ApS
Effective date
2010-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:07

Label at a glance#

ProductPoly Bacitracin
Active ingredientBacitracin zinc, Polymyxin B sulfate
Label structure10 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

Storage and handling

To open: unscrew cap, pull tab to remove foil seal. store at 20°-25°C (68°-77°F) See carton or tube crimp for lot number and expiration date.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (each gram contains) Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

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 persists or gets worse
  • you need to use longer than 1 week
  • 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

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, pull tab to remove foil seal.
  • store at 20°-25°C (68°-77°F)
  • See carton or tube crimp for lot number and expiration date.

Inactive ingredient

INACTIVE INGREDIENT SECTION

white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-877-745-6888

SPL UNCLASSIFIED SECTION

Distributed by:
Phoenix Global Supply Group, Inc.
White Plains, NY 10604

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Poly Bacitracin
Bacitracin Zinc • Polymyxin B Sulfate

First Aid Antibiotic Ointment

NDC 52426-420-06

NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
Principal Display Panel - 28.4 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN1
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD1
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52426-420-052019-10-29C16284748780-1960f7f55-c7a3-8e05-e053-dbdaa90a074aPoly Bacitracin
52426-420-062019-10-29C16284748780-1960f7f55-c7a3-8e05-e053-dbdaa90a074aPoly Bacitracin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52426-420-05Poly Bacitracin14.2 g in 1 TUBEOINTMENT14.21
52426-420-05Poly Bacitracin1 in 1 CARTONOINTMENT11
52426-420-06Poly Bacitracin1 in 1 CARTONOINTMENT11
52426-420-06Poly Bacitracin28.4 g in 1 TUBEOINTMENT28.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52426-420POLY BACITRACIN (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [PHOENIX GLOBAL SUPPLY GROUP, INC]1Legacy NDC, 4 package rows20101014_3ff16a04-2060-434b-9f62-38e7a38deb95.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bacitracin zincACTIVE INGREDIENT89Y4M234ES1
Polymyxin B sulfateACTIVE INGREDIENT19371312D41
Bacitracin zincACTIVE MOIETY89Y4M234ES1
Polymyxin BACTIVE MOIETYJ2VZ07J96K1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52426-42052426-420-05, 52426-420-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bacitracin zinc89Y4M234ESACTIB
Polymyxin B sulfate19371312D4ACTIB
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
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact 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
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact 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
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 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
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact 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
4a970118-6a7f-4fa1-b822-442a96d20f5b3ff16a04-2060-434b-9f62-38e7a38deb952010-09-28WarningsExact identifier
spl id: 4a970118-6a7f-4fa1-b822-442a96d20f5b
spl set id: 3ff16a04-2060-434b-9f62-38e7a38deb95

Reported adverse events (FAERS/openFDA)#

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