FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
Dealmed Medical Supplies LLC | Safetec of America, Inc.
Effective date
2022-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:48

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, scrapes and burns

Dosage and administration

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 daily may be covered with a sterile bandage

Label contents#

Full prescribing information#

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 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 and burns

Warnings

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

  • in the eyes
  • internally
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask a doctor before use:

OTC - ASK DOCTOR SECTION

  • in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
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
  • 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

OTHER SAFETY INFORMATION

  • store at room temperature (do not freeze)
  • do Not Use any Opened or Torn Packets

Inactive ingredient

INACTIVE INGREDIENT SECTION

petrolatum

Questions or Comments?

OTC - QUESTIONS SECTION

1 -800-456-7077

Principal Display Panel - 0.5 g Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70082-603-04

dealmed

Triple
Antibiotic
Ointment

First Aid to help prevent
infection in minor cuts,
scrapes and burns

144
PACKETS

NET WT. 0.5g
PER PACKET

Principal Display Panel - 0.5 g Box Label
Principal Display Panel - 0.5 g Box Label

Principal Display Panel - 0.5g Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dealmed

Triple Antibiotic
Ointment

0.5g (1/57 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com

Principal Display Panel - 0.5g Pouch Label
Principal Display Panel - 0.5g Pouch Label

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
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
70082-603-042024-01-30C16284748780-11030e365-0c2a-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70082-603-04Triple Antibiotic144 in 1 BOXOINTMENT1441
70082-603-04Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70082-603TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [DEALMED MEDICAL SUPPLIES LLC]1Legacy NDC, 2 package rows20220318_edb84ac1-f002-473a-82b0-71d5cf1424ed.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
70082-60370082-603-04

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 sulfate057Y626693ACTIB
polymyxin b sulfate19371312D4ACTIM
petrolatum4T6H12BN9UIACT

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
60801a35-c220-49f5-a843-9893476272b0edb84ac1-f002-473a-82b0-71d5cf1424ed2022-03-08WarningsExact identifier
spl id: 60801a35-c220-49f5-a843-9893476272b0
spl set id: edb84ac1-f002-473a-82b0-71d5cf1424ed

Reported adverse events (FAERS/openFDA)#

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