FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
ProStat First Aid
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:25:32

Label at a glance#

ProductTriple Antibiotic
Active ingredientNEOMYCIN SULFATE, BACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure11 sections

Dosage and administration

Clean the affected area. Apply a small amount of the 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#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 400 Units

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Neomycin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Polymyxin B Sulfate 5000 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Use(s)

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 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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

• The condition persists or gets worse

• A rash or other allergic reaction develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area. Apply a small amount of the 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

OTHER SAFETY INFORMATION

• Store at room temperature between 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if packet is torn, cut, or opened.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

White Petrolatum

Questions?

OTC - QUESTIONS SECTION

1-888-900-2920 Monday - Friday 8AM - 4PM PST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PS-2009-BX-MASTERPS-2009-BX-MASTERTriple Antibiotic Ointment

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
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130814889010162GTIN-13: 0814889010162
EAN-13: 0814889010162
GTIN-12: 814889010162
UPC-A: 814889010162
GTIN storage (14 digits): 00814889010162		PS-2009-BX-MASTER-R230123-8.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-2009-1Triple Antibiotic25 in 1 BOXOINTMENT253
58228-2009-1Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.53
58228-2009-2Triple Antibiotic1800 in 1 CASEOINTMENT18003

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58228-200958228-2009-1, 58228-2009-2

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
WHITE PETROLATUMB6E5W8RQJ4IACT
NEOMYCIN SULFATE057Y626693ACTIM
BACITRACIN ZINC89Y4M234ESACTIM
POLYMYXIN B SULFATE19371312D4ACTIM

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
46013f47-af0c-7b00-e063-6294a90aa9b3f76d7d18-0fa1-d943-e053-6294a90ac20a2025-12-15WarningsExact identifier
spl id: 46013f47-af0c-7b00-e063-6294a90aa9b3
spl set id: f76d7d18-0fa1-d943-e053-6294a90ac20a

Reported adverse events (FAERS/openFDA)#

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