FDA.reportPublic FDA data

triple antibiotic

Manufacturer
Acme United Corporation | Safetec of America, Inc.
Effective date
2016-03-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:45:23

Label at a glance#

Producttriple antibiotic
Active ingredientbacitracin zinc, neomycin sulfate, polymyxin b sulfate
Label structure12 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 a finger) on the area 1 to 3 times daily may be covered with a sterile bandage

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 400 units

Neomycin sulfate 5 mg (equivalent to 3.5 mg of neomycin base)

Polymyxin-B sulfate 5000 units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotics

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

  • 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 you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition persists or gets worse
  • A rash or other allergic reaction develops
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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 a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Other information

SPL UNCLASSIFIED SECTION

  • Store at 15° to 25° C (59° to 77° F)
  • Do not use if packet is open or torn

Inactive ingredient

INACTIVE INGREDIENT SECTION

Petrolatum

Questions? 1-800-835-2263

OTC - QUESTIONS SECTION

Manufactured for:
Acme United Corporation
Fairfield, CT 06824

REORDER
www.PhysiciansCareFirstAid.com
1 800 835 2263

Principal Display Panel - Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRST AID ONLY®

Triple
Antibiotic

Ointment

NET WT 1/57 oz (0.5g)

www.FirstAidOnly.com

Fairfield, CT 06824

1.800.835.2263

© 2015 Acme United Corporation.

Principal Display Panel - Packet Label
Principal Display Panel - Packet Label

PRINCIPAL DISPLAY PANEL – 10 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PhysiciansCARE

Antibiotic
Ointment

Bacitracin zinc Neomycin sulfate Polymyxin B sulfate
10 Single use Packets 0.5g each

Reorder No. 12944

ANSI Z308.1

PRINCIPAL DISPLAY PANEL – 10 count box
PRINCIPAL DISPLAY PANEL – 10 count box

PRINCIPAL DISPLAY PANEL – 12 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12-001
ANTISEPTICS

FIRST AID ONLY®

Triple Antibiotic Ointment

12 (0.5g) Packets

Pomada con triple antibiótico

12 sobres de (0.5g)

PRINCIPAL DISPLAY PANEL – 12 count box
PRINCIPAL DISPLAY PANEL – 12 count box

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 OintmentPSN5
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5

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
0924-5603-032020-01-31C16284748780-19d75b9d0-0730-f424-e053-dadaa90a57cedea732fa-524b-4f75-bfee-285c30e74bdc
0924-5603-082020-01-31C16284748780-19d75b9d0-0730-f424-e053-dadaa90a57cedea732fa-524b-4f75-bfee-285c30e74bdc
0924-5603-092020-01-31C16284748780-19d75b9d0-0730-f424-e053-dadaa90a57cedea732fa-524b-4f75-bfee-285c30e74bdc
0924-5603-102020-01-31C16284748780-19d75b9d0-0730-f424-e053-dadaa90a57cedea732fa-524b-4f75-bfee-285c30e74bdc
0924-5603-112020-01-31C16284748780-19d75b9d0-0730-f424-e053-dadaa90a57cedea732fa-524b-4f75-bfee-285c30e74bdc
0924-5603-122020-01-31C16284748780-19d75b9d0-0730-f424-e053-dadaa90a57cedea732fa-524b-4f75-bfee-285c30e74bdc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5603-01triple antibiotic0.5 g in 1 PACKETOINTMENT0.55
0924-5603-03triple antibiotic10 in 1 BOXOINTMENT105
0924-5603-08triple antibiotic10 in 1 BOXOINTMENT105
0924-5603-09triple antibiotic12 in 1 BOXOINTMENT125
0924-5603-10triple antibiotic60 in 1 BOXOINTMENT605
0924-5603-11triple antibiotic144 in 1 BOXOINTMENT1445
0924-5603-12triple antibiotic25 in 1 BOXOINTMENT255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5603TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]5Legacy NDC, 7 package rows20160310_dea732fa-524b-4f75-bfee-285c30e74bdc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ES3
neomycin sulfateACTIVE INGREDIENT057Y6266933
polymyxin b sulfateACTIVE INGREDIENT19371312D43
bacitracinACTIVE MOIETY58H6RWO52I3
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 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-56030924-5603-01, 0924-5603-03, 0924-5603-08, 0924-5603-09, 0924-5603-10, 0924-5603-11, 0924-5603-12

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
bacitracin zinc89Y4M234ESACTIM
neomycin sulfate057Y626693ACTIM
polymyxin b sulfate19371312D4ACTIM
petrolatum4T6H12BN9UIACT

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
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact 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
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %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
88a6e851-4ee2-49e8-a918-546cf5f17797dea732fa-524b-4f75-bfee-285c30e74bdc2016-03-09WarningsExact identifier
spl id: 88a6e851-4ee2-49e8-a918-546cf5f17797
spl set id: dea732fa-524b-4f75-bfee-285c30e74bdc

Reported adverse events (FAERS/openFDA)#

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