FDA.reportPublic FDA data

triple antibiotic plus

Manufacturer
Meijer, Inc.
Effective date
2018-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:47

Label at a glance#

Producttriple antibiotic plus
Active ingredientNEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure16 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each gram) Purposes

Bacitracin zinc 500 units........................First Aid antibiotic

Neomycin sulfate 3.5 mg.......................First Aid antibiotic

Polymyxin B sulfate 10,000 units...........First Aid antibiotic

Pramoxine HCl 10 mg............................First Aid antibiotic

OTC - PURPOSE SECTION

Uses

  • first aid to help prevent infection and for the temporary relief of pain in minor:
  • cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes or nose
  • over large areas of the body

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • rash or other allergic reaction develops
  • symptoms persist for more than 1 week or clear up and occur again within a few days
  • condition persists or gets worse
  • redness, irritation, swelling, or pain persists or increases

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

  • adults and children 2 years of age and older:
  • 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
  • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingrdients alcohol, methylparaben, mineral oil, petrolatum, polyoxl 40 stearate, propylparaben

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-814-8028

DOSAGE & ADMINISTRATION SECTION

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

MADE IN SOUTH KOREA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9402894028

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9403794037

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9402994029

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 OintmentPSN1
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD1
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY1

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
41250-961-142022-01-28C16284748780-1d6a99b39-d15f-a426-e053-dadaa90af4c2Meijer Triple Antibiotic Plus Pain Relief Ointment 0.5oz (94028, 2018) Meijer Triple Antibiotic Plus Pain Relief Ointment 1.0oz (94037, 2018) Meijer Triple Antibiotic Plus Pain Relief Ointment 1.0oz Twin (94029, 2018)
41250-961-282022-01-28C16284748780-1d6a99b39-d15f-a426-e053-dadaa90af4c2Meijer Triple Antibiotic Plus Pain Relief Ointment 0.5oz (94028, 2018) Meijer Triple Antibiotic Plus Pain Relief Ointment 1.0oz (94037, 2018) Meijer Triple Antibiotic Plus Pain Relief Ointment 1.0oz Twin (94029, 2018)
41250-961-562022-01-28C16284748780-1d6a99b39-d15f-a426-e053-dadaa90af4c2Meijer Triple Antibiotic Plus Pain Relief Ointment 0.5oz (94028, 2018) Meijer Triple Antibiotic Plus Pain Relief Ointment 1.0oz (94037, 2018) Meijer Triple Antibiotic Plus Pain Relief Ointment 1.0oz Twin (94029, 2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-961-14triple antibiotic plus14 g in 1 TUBEOINTMENT141
41250-961-14triple antibiotic plus1 in 1 CARTONOINTMENT11
41250-961-28triple antibiotic plus1 in 1 CARTONOINTMENT11
41250-961-28triple antibiotic plus28 g in 1 TUBEOINTMENT281
41250-961-56triple antibiotic plus2 in 1 CARTONOINTMENT21
41250-961-56triple antibiotic plus28 g in 1 TUBEOINTMENT281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-961TRIPLE ANTIBIOTIC PLUS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MEIJER, INC.]1Legacy NDC, 6 package rows20181219_7d532272-b7b2-1144-e053-2a91aa0af752.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-96141250-961-14, 41250-961-56, 41250-961-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
NEOMYCIN SULFATE057Y626693ACTIB
MINERAL OILT5L8T28FGPIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIM
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
587f170a-a8d6-a754-e063-6294a90ade6d7d532272-b7b2-1144-e053-2a91aa0af7522026-08-07WarningsExact identifier
spl set id: 7d532272-b7b2-1144-e053-2a91aa0af752

Reported adverse events (FAERS/openFDA)#

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