FDA.reportPublic FDA data

triple antibiotic

Manufacturer
Acme United Corporation | Safetec of America, Inc.
Effective date
2012-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:17

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 and scrapes Minor burns

Dosage and administration

Tamper evident packaging, do not use if packet is opened or torn. Clean the affected area, apply a small amount of this product (equal to the surface area of a fingertip) 1 to 3 times daily

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(Each gram contains)

Bacitracin 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 and scrapes
  • Minor burns

Warnings:

WARNINGS SECTION

For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

STOP USE AND ASK A DOCTOR IF:

OTC - STOP USE SECTION

  • Conditions worsen or clear up and then recur
  • The condition persists for more than 7 days
  • A rash or allergic reaction occurs

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 ingredients
  • Longer than 1 week unless directed by a doctor
  • On raw surfaces, blistered areas or serious burns
  • For deep lacerations or puncture wounds

WHEN USING THIS PRODUCT:

OTC - WHEN USING SECTION

  • Avoid contact with the eyes or mucus membranes

Directions:

DOSAGE & ADMINISTRATION SECTION

Tamper evident packaging, do not use if packet is opened or torn.

Adults and children:

SPL UNCLASSIFIED SECTION

Clean the affected area, apply a small amount of this product (equal to the surface area of a fingertip) 1 to 3 times daily

Other information:

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Petrolatum

PRINCIPAL DISPLAY PANEL – packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0924-5603-01

PhysiciansCARE

Triple Antibiotic
Ointment

0.5 g (1/57 oz.)

Acme United Corporation

Fairfield, CT 06824 800-835-2263

PRINCIPAL DISPLAY PANEL – packet
PRINCIPAL DISPLAY PANEL – packet

PRINCIPAL DISPLAY PANEL – 12 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAC-KIT FIRST AID

UNIT
12-001

12 EACH

Triple Antibiotic
Ointment Packets

Contains 12 ea. First Aid Antibiotic ointment packets
(min. weight each, 0.5 gm) to help prevent infection in minor cuts,
scrapes and burns. See back panel for Drug Facts listing.

Distributed by Acme United Corporation Fairfield, CT 06824 · 800-835-2263

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 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
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0924-5603-042020-01-31C16284748780-19d75b9d0-2c05-f424-e053-dadaa90a57ce2ac1f9bb-2766-47eb-b25d-ac70f671a309
0924-5603-052020-01-31C16284748780-19d75b9d0-2c05-f424-e053-dadaa90a57ce2ac1f9bb-2766-47eb-b25d-ac70f671a309
0924-5603-062020-01-31C16284748780-19d75b9d0-2c05-f424-e053-dadaa90a57ce2ac1f9bb-2766-47eb-b25d-ac70f671a309
0924-5603-072020-01-31C16284748780-19d75b9d0-2c05-f424-e053-dadaa90a57ce2ac1f9bb-2766-47eb-b25d-ac70f671a309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5603-01triple antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5603-04triple antibiotic12 in 1 BOXOINTMENT121
0924-5603-05triple antibiotic25 in 1 BOXOINTMENT251
0924-5603-06triple antibiotic60 in 1 BOXOINTMENT601
0924-5603-07triple antibiotic144 in 1 BOXOINTMENT1441

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]1Legacy NDC, 5 package rows20120330_2ac1f9bb-2766-47eb-b25d-ac70f671a309.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ES1
neomycin sulfateACTIVE INGREDIENT057Y6266931
polymyxin b sulfateACTIVE INGREDIENT19371312D41
bacitracin zincACTIVE MOIETY89Y4M234ES1
neomycinACTIVE MOIETYI16QD7X2971
polymyxin bACTIVE MOIETYJ2VZ07J96K1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1

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
0924-56030924-5603-01, 0924-5603-04, 0924-5603-05, 0924-5603-06, 0924-5603-07

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 zinc89Y4M234ESACTIB
neomycin sulfate057Y626693ACTIM
polymyxin b sulfate19371312D4ACTIB
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
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact 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
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, EXTENDED RELEASE / ORAL0.18 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
589803b1-7e58-4e60-9ac5-b17fe07d04742ac1f9bb-2766-47eb-b25d-ac70f671a3092012-03-28WarningsExact identifier
spl id: 589803b1-7e58-4e60-9ac5-b17fe07d0474
spl set id: 2ac1f9bb-2766-47eb-b25d-ac70f671a309

Reported adverse events (FAERS/openFDA)#

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