FDA.reportPublic FDA data

First Aid Only Triple Antibiotic Ointment

Manufacturer
Acme united Corporation | Water-Jel Technologies
Effective date
2019-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:28

Label at a glance#

ProductFirst Aid Only Triple Antibiotic
Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE
Label structure9 sections

Indications and uses

First aid to help prevent infection in minor •cuts •scrapes •burns

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 400 units

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

Polymyxin B sulfate 5000 units

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

First aid antibiotic

First 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

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

OTC - STOP USE SECTION

Stop use and ask a doctor if •condition persists or gets worse, •a rash or allergic reaction occurs, •the condition persists for more than 7 days

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 immediately.

DOSAGE & ADMINISTRATION SECTION

Adults and Children 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 ingredient

INACTIVE INGREDIENT SECTION

petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

Questions 1.800.835.2263

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Image Carton ImageCarton Image

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
0924-5605-012023-01-30C16284748780-1f386c64a-4656-0266-e053-dadaa90a7c1aFirst Aid Only Triple Antibiotic Ointment
0924-5605-022023-01-30C16284748780-1f386c64a-4656-0266-e053-dadaa90a7c1aFirst Aid Only Triple Antibiotic Ointment
0924-5605-032023-01-30C16284748780-1f386c64a-4656-0266-e053-dadaa90a7c1aFirst Aid Only Triple Antibiotic Ointment
0924-5605-042023-01-30C16284748780-1f386c64a-4656-0266-e053-dadaa90a7c1aFirst Aid Only Triple Antibiotic Ointment
0924-5605-052023-01-30C16284748780-1f386c64a-4656-0266-e053-dadaa90a7c1aFirst Aid Only Triple Antibiotic Ointment
0924-5605-062023-01-30C16284748780-1f386c64a-4656-0266-e053-dadaa90a7c1aFirst Aid Only Triple Antibiotic Ointment
0924-5605-072023-01-30C16284748780-1f386c64a-4656-0266-e053-dadaa90a7c1aFirst Aid Only Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5605-01First Aid Only Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5605-02First Aid Only Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5605-02First Aid Only Triple Antibiotic6 in 1 BAGOINTMENT61
0924-5605-03First Aid Only Triple Antibiotic10 in 1 CARTONOINTMENT101
0924-5605-03First Aid Only Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5605-04First Aid Only Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5605-04First Aid Only Triple Antibiotic12 in 1 CARTONOINTMENT121
0924-5605-05First Aid Only Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5605-05First Aid Only Triple Antibiotic25 in 1 BOX, UNIT-DOSEOINTMENT251
0924-5605-06First Aid Only Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5605-06First Aid Only Triple Antibiotic60 in 1 CARTONOINTMENT601
0924-5605-07First Aid Only Triple Antibiotic144 in 1 BOX, UNIT-DOSEOINTMENT1441
0924-5605-07First Aid Only Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5605FIRST AID ONLY TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [ACME UNITED CORPORATION]1Legacy NDC, 13 package rows20191113_972cabf7-cdce-67ce-e053-2a95a90af92f.zip

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
0924-56050924-5605-07, 0924-5605-05, 0924-5605-06, 0924-5605-04, 0924-5605-03, 0924-5605-01, 0924-5605-02

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
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
NEOMYCIN SULFATE057Y626693ACTIM

Source Document#

Source XML · Source PDF

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
972c8d85-4d55-95e3-e053-2a95a90a4cd5972cabf7-cdce-67ce-e053-2a95a90af92f2019-11-12WarningsExact identifier
spl id: 972c8d85-4d55-95e3-e053-2a95a90a4cd5
spl set id: 972cabf7-cdce-67ce-e053-2a95a90af92f

Reported adverse events (FAERS/openFDA)#

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