FDA.reportPublic FDA data

Antibiotic Application

Manufacturer
CMC Group, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:52:43

Label at a glance#

ProductAntibiotic Application
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure7 sections

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#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Use

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 • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or punture wounds • animal bites • 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 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 room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, petrolatum, purified water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibiotic ApplicationAntibiotic Application

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 OintmentPSN7
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD7
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY7

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
49687-0013-02025-01-14C16284748780-19d75b9d1-27bd-f424-e053-dadaa90a57ceAntibiotic Application
49687-0013-02024-01-30C16284748780-19d75b9d1-27bd-f424-e053-dadaa90a57ceAntibiotic Application
49687-0013-02020-02-03C16284748780-19d75b9d1-27bd-f424-e053-dadaa90a57ceAntibiotic Application
49687-0013-02020-01-31C16284748780-19d75b9d1-27bd-f424-e053-dadaa90a57ceAntibiotic Application

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0013-0Antibiotic Application0.9 g in 1 PACKAGEOINTMENT0.97
49687-0013-0Antibiotic Application10 in 1 KITOINTMENT107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0013ANTIBIOTIC APPLICATION (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [CMC GROUP, INC.]7Current NDC, Legacy NDC, 2 package rows20250116_da436c35-a98f-4df7-9d23-885564734cef.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49687-001349687-0013-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
ndc (package): 49687-0013-0
ndc11 (package): 49687001300
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
ndc (package): 49687-0013-0
ndc11 (package): 49687001300
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
ndc (package): 49687-0013-0
ndc (product): 49687-0013
ndc11 (package): 49687001300
spl id: 2b9b528b-164e-a4d3-e063-6294a90a5318
spl set id: da436c35-a98f-4df7-9d23-885564734cef
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
ndc (package): 49687-0013-0
ndc11 (package): 49687001300

Reported adverse events (FAERS/openFDA)#

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