FDA.reportPublic FDA data

Triple Antibiotic First Aid Antibiotic Ointment

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd
Effective date
2020-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:11

Label at a glance#

ProductTriple Antibiotic First Aid Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

OTC - PURPOSE SECTION

Purpose

First Aid Antibiotic

INDICATIONS & USAGE SECTION

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use on

  • on deep puncture wounds, animal bites, or serious burns

OTC - STOP USE SECTION

Stop use and consult a doctor if the condition persists or gets worse, or if 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean the affected area and dry thoroughly
  • May be covered with a sterile bandage
  • 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

SPL UNCLASSIFIED SECTION

Other Information

  • Store at 20°C to 25°C (68°F to 77°C)
  • Lot No. & Exp. Date: see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive Ingredients

cocoa butter, cotton seed oil, olive oil,  sodium pyruvate, vitamin E, white petrolatum, hard parrafin, mineral oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Triple Antibiotic First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

labellabel

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
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
47046-154-022022-01-28C16284748780-1d6a99b39-e77a-a426-e053-dadaa90af4c2Triple Antibiotic First Aid Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-154-01Triple Antibiotic First Aid Antibiotic14 g in 1 TUBEOINTMENT141
47046-154-02Triple Antibiotic First Aid Antibiotic1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-154TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [ANICARE PHARMACEUTICALS PVT. LTD]1Legacy NDC, 2 package rows20201215_b659d3cf-97c4-5ca2-e053-2a95a90a9371.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
47046-15447046-154-01, 47046-154-02

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
WHITE PETROLATUMB6E5W8RQJ4IACT
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
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
b659bc8d-5c59-2503-e053-2995a90a217db659d3cf-97c4-5ca2-e053-2a95a90a93712020-12-13WarningsExact identifier
spl id: b659bc8d-5c59-2503-e053-2995a90a217d
spl set id: b659d3cf-97c4-5ca2-e053-2a95a90a9371

Reported adverse events (FAERS/openFDA)#

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