FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
Pharmacy Value Alliance LLC
Effective date
2017-05-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:50

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 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° to 25°C (68° to 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 (in each gram)Purpose
Bacitracin zinc USP 400 unitsFirst aid antibiotic
Neomycin sulfate USP 3.5 mgFirst aid antibiotic
Polymyxin B sulfate USP 5,000 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.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use longer than 1 week
  • condition persists or gets worse
  • 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° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue, Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier
Value ®

Triple Antibiotic
Ointment

• Bacitracin Zinc • Neomycin Sulfate
• Polymyxin B Sulfate

FIRST AID ANTIBIOTIC OINTMENT

NET WT 1 oz (28.4 g)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

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
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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
68016-120-012025-07-29C16284748780-13b156c62-2bc3-fb37-e063-e6dba90a4e07Triple Antibiotic
68016-120-022025-07-29C16284748780-13b156c62-2bc3-fb37-e063-e6dba90a4e07Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-120-01Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.21
68016-120-01Triple Antibiotic1 in 1 CARTONOINTMENT11
68016-120-02Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.41
68016-120-02Triple Antibiotic1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-120TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PHARMACY VALUE ALLIANCE LLC]1Legacy NDC, 4 package rows20170512_0aa3818d-1f00-48c1-902b-2998f6a53cc2.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-12068016-120-01, 68016-120-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bacitracin Zinc89Y4M234ESACTIM
Neomycin Sulfate057Y626693ACTIB
Polymyxin B Sulfate19371312D4ACTIM
sucroseC151H8M554IACT
cottonseed oilH3E878020NIACT
olive oil6UYK2W1W1EIACT
sodium pyruvatePOD38AIF08IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
petrolatum4T6H12BN9UIACT

Source Document#

Source XML

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
3f7907ca-b762-4f4c-94d5-40612028858e0aa3818d-1f00-48c1-902b-2998f6a53cc22017-05-11WarningsExact identifier
spl id: 3f7907ca-b762-4f4c-94d5-40612028858e
spl set id: 0aa3818d-1f00-48c1-902b-2998f6a53cc2

Reported adverse events (FAERS/openFDA)#

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