FDA.reportPublic FDA data

Meijer Triple Antibiotic + Pain Relief Ointment

Manufacturer
Meijer | Trifecta Pharmaceuticals USA
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:53:12

Label at a glance#

ProductTriple antibiotic and pain relief
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE, POLYMYXIN B SULFATE
Label structure18 sections

Indications and uses

First Aid to help prevent infection in minor: Cuts Scrapes Burns

Dosage and administration

Clean the affected area thoroughly 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

Storage and handling

To Open: Unscrew cap, pull tab to remove foil seal Store at 20° to 25°C (68° to 77°F) See carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 500 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Neomycin Sulfate 3.5mg

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Polymyxin B Sulfate 10,000 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCL 10mg

Purpose

OTC - PURPOSE SECTION

External Analgesic

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:

  • In eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients

Ask a Doctor before Use

OTC - ASK DOCTOR SECTION

Ask Doctor before use if you have:

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Stop Use and ask a Doctor if:

OTC - STOP USE SECTION

  • Condition persists or gets worse
  • You need to use longer than 1 week
  • 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area thoroughly
  • 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

STORAGE AND HANDLING SECTION

  • To Open: Unscrew cap, pull tab to remove foil seal
  • Store at 20° to 25°C (68° to 77°F)
  • See carton or tube crimp for lot number and expiration date

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2726957 Meijer Triple Antibiotic Ointment Pain Relief2726957 Meijer Triple Antibiotic Ointment Pain Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN6
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD6
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY6

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79481-0016-12025-01-30C16284748780-12cef2736-a431-d83d-e063-dadaa90ab31fMeijer Triple Antibiotic + Pain Relief Ointment
79481-0016-22025-01-30C16284748780-12cef2736-a431-d83d-e063-dadaa90ab31fMeijer Triple Antibiotic + Pain Relief Ointment
79481-0016-52025-01-30C16284748780-12cef2736-a431-d83d-e063-dadaa90ab31fMeijer Triple Antibiotic + Pain Relief Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0016-1Triple antibiotic and pain relief1 in 1 BOXOINTMENT16
79481-0016-1Triple antibiotic and pain relief28 g in 1 TUBEOINTMENT286
79481-0016-2Triple antibiotic and pain relief1 in 1 BOXOINTMENT16
79481-0016-2Triple antibiotic and pain relief2 in 1 PACKAGE, COMBINATIONOINTMENT26
79481-0016-5Triple antibiotic and pain relief14 g in 1 TUBEOINTMENT146
79481-0016-5Triple antibiotic and pain relief1 in 1 BOXOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0016TRIPLE ANTIBIOTIC AND PAIN RELIEF (BACITRACIN,NEOMYCIN,POLYMYXIN, PRAMOXINE) OINTMENT [MEIJER]6Legacy NDC, 6 package rows20230112_c59a94ef-63d7-50d7-e053-2995a90ae125.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
79481-001679481-0016-2, 79481-0016-1, 79481-0016-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIB
NEOMYCIN SULFATE057Y626693ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
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
f202600b-ca3a-f1c9-e053-2a95a90ab17ec59a94ef-63d7-50d7-e053-2995a90ae1252023-01-11WarningsExact identifier
spl id: f202600b-ca3a-f1c9-e053-2a95a90ab17e
spl set id: c59a94ef-63d7-50d7-e053-2995a90ae125

Reported adverse events (FAERS/openFDA)#

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