FDA.reportPublic FDA data

TheraCare First Aid Triple Antibiotic Ointment

Manufacturer
Veridian Healthcare | ANICARE PHARMACEUTICALS PRIVATE LIMITED
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:56

Label at a glance#

ProductTheraCare First Aid Triple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure7 sections

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

Storage and handling

store at 20° to 25°C (68° to 77° F) do not use if tube seal under cap is broken

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Bacitracin zinc
  • Neomycin sulfate
  • Polymyxin B Sulfate

OTC - PURPOSE SECTION

Active ingredients (in each gram) Purpose
Bacitracin 400 unitsFirst aid antibiotic
Neomycin 3.5 mgFirst aid antibiotic
Polymyxin B 5,000 unitsFirst aid antibiotic

Use

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

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using this product

OTC - WHEN USING SECTION

use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use longer than 1 week
  • condition persists or gets worse
  • 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.(1-800-222-1222)

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

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77° F)
  • do not use if tube seal under cap is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

alpha-tocopherol acetate, cocoa butter, cottonseed oil, light mineral oil, olive oil, paraffin, petrolatum, sodium pyruvate

TheraCare First Aid Triple Antibiotic Ointment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelPackPack

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 OintmentPSN2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
71101-210-012025-07-29C16284748780-13b156c62-2693-fb37-e063-e6dba90a4e07TheraCare First Aid Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-210-01TheraCare First Aid Triple Antibiotic1 in 1 CARTONOINTMENT12
71101-210-01TheraCare First Aid Triple Antibiotic28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-210THERACARE FIRST AID TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [VERIDIAN HEALTHCARE]2Legacy NDC, 2 package rows20241220_c16093e0-6002-6ba0-e053-2995a90a06a3.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
71101-21071101-210-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCOA BUTTER512OYT1CRRIACT
COTTONSEED OILH3E878020NIACT
OLIVE OIL6UYK2W1W1EIACT
SODIUM PYRUVATEPOD38AIF08IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
LIGHT MINERAL OILN6K5787QVPIACT
PARAFFINI9O0E3H2ZEIACT

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
299514c6-0462-7bd2-e063-6294a90af9b3c16093e0-6002-6ba0-e053-2995a90a06a32024-12-18WarningsExact identifier
spl id: 299514c6-0462-7bd2-e063-6294a90af9b3
spl set id: c16093e0-6002-6ba0-e053-2995a90a06a3

Reported adverse events (FAERS/openFDA)#

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