FDA.reportPublic FDA data

ANCALIMA

Manufacturer
ANCALIMA LIFESCIENCES LIMITED
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:49

Label at a glance#

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

Indications and uses

■ first aid to help prevent infection in ■ minor cuts ■ scrapes ■ 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

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Purpose

OTC - PURPOSE SECTION

First Aid AntibioticFirst Aid AntibioticFirst Aid Antibiotic

Uses

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

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

Ask a physician before use in case of

OTC - ASK DOCTOR SECTION

■ deep or puncture wounds ■ animal bites ■ serious burns

Stop use and consult 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

SPL UNCLASSIFIED SECTION

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

white petrolatum

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display & Drug Fact PanelPrincipal Display & Drug Fact Panel

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
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
73014-3025-22023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic
73014-3025-32023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic
73014-3025-42023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic
73014-3025-52023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73014-3025-2ANCALIMAFirst Aid0.5 g in 1 PACKETOINTMENT0.52
73014-3025-3ANCALIMAFirst Aid0.9 g in 1 PACKETOINTMENT0.92
73014-3025-4ANCALIMAFirst Aid14 g in 1 TUBEOINTMENT142
73014-3025-5ANCALIMAFirst Aid28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73014-3025ANCALIMA FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ANCALIMA LIFESCIENCES LIMITED]2Legacy NDC, 4 package rows20210113_860ecb50-9cbb-fe33-e053-2991aa0a744b.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
73014-302573014-3025-2, 73014-3025-3, 73014-3025-4, 73014-3025-5

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
PETROLATUM4T6H12BN9UIACT
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
b8b4c69a-ed0d-78b1-e053-2a95a90ade8b860ecb50-9cbb-fe33-e053-2991aa0a744b2021-01-12WarningsExact identifier
spl id: b8b4c69a-ed0d-78b1-e053-2a95a90ade8b
spl set id: 860ecb50-9cbb-fe33-e053-2991aa0a744b

Reported adverse events (FAERS/openFDA)#

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