Triple Antibiotic Ointment First Aid Antibiotic

Manufacturer
Chain Drug Marketing Association | Trifecta Pharmaceuticals USA
Effective date
2023-05-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:05

Label at a glance#

ProductTriple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure15 sections

Dosage and administration

● clean the affected area and dry 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.

Label contents#

Full prescribing information#

Active ingredients (each gram contains)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg 
Polymyxin B sulfate 5,000 units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic Ointment

INDICATIONS & USAGE SECTION

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

WARNINGS SECTION

Warnings 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

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

Ask Doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

● clean the affected area and dry 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

SPL UNCLASSIFIED 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 SECTION

Inactive ingredientMineral Oil, Petrolatum

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc. ©
43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information:

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered trademark Neosporin®

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic OintmentTriple Antibiotic Ointment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment .5oz.Triple Antibiotic Ointment .5oz.

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 OintmentPSN3
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD3
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY3

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-459-05Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.23
63868-459-05Triple Antibiotic1 in 1 BOXOINTMENT13
63868-459-10Triple Antibiotic1 in 1 BOXOINTMENT13
63868-459-10Triple Antibiotic28.3 g in 1 TUBEOINTMENT28.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-459TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION]3Legacy NDC, 4 package rows20230526_8501adcd-97e1-bd25-e053-2a91aa0ad747.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-459-05GM - Gram63868-459e1060249-cf63-49f4-b7b1-08ec64b7c32812022-09-12
63868-459-10GM - Gram63868-45966e2d87b-7764-455d-bdc4-12b94df2363d12022-10-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-45963868-459-10, 63868-459-05

Ingredients#

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

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

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
fc8792f6-199f-d6e3-e053-6394a90a2ccb8501adcd-97e1-bd25-e053-2a91aa0ad7472023-05-25WarningsExact identifier
spl id: fc8792f6-199f-d6e3-e053-6394a90a2ccb
spl set id: 8501adcd-97e1-bd25-e053-2a91aa0ad747

Reported adverse events (FAERS/openFDA)#

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