FDA.reportPublic FDA data

Ancalima Bacitracin Zinc

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 Bacitracin Zinc First Aid
Active ingredientBACITRACIN ZINC
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 Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

OTC - PURPOSE SECTION

First 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

■ Not for opthalmic use Do not use ■ 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 doctor before use in case of

OTC - ASK DOCTOR SECTION

■ deep or puncture wounds

■ animal bites ■ 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

Keep out of reach of children

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

hard paraffin, liquid paraffin, white soft paraffin, lanolin

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
1648110bacitracin 500 UNT in GM Topical OintmentPSN2
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD2
1648110bacitracin 500 UNT per GM Topical OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73014-3035-22023-01-30C16284748780-1f386c649-9b3e-0266-e053-dadaa90a7c1aANCALIMA Bacitracin Zinc
73014-3035-32023-01-30C16284748780-1f386c649-9b3e-0266-e053-dadaa90a7c1aANCALIMA Bacitracin Zinc
73014-3035-42023-01-30C16284748780-1f386c649-9b3e-0266-e053-dadaa90a7c1aANCALIMA Bacitracin Zinc
73014-3035-52023-01-30C16284748780-1f386c649-9b3e-0266-e053-dadaa90a7c1aANCALIMA Bacitracin Zinc
73014-3035-62023-01-30C16284748780-1f386c649-9b3e-0266-e053-dadaa90a7c1aANCALIMA Bacitracin Zinc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73014-3035-2Ancalima Bacitracin ZincFirst Aid0.9 g in 1 PACKETOINTMENT0.92
73014-3035-3Ancalima Bacitracin ZincFirst Aid14 g in 1 TUBEOINTMENT142
73014-3035-4Ancalima Bacitracin ZincFirst Aid28 g in 1 TUBEOINTMENT282
73014-3035-5Ancalima Bacitracin ZincFirst Aid113 g in 1 TUBEOINTMENT1132
73014-3035-6Ancalima Bacitracin ZincFirst Aid425 g in 1 JAROINTMENT4252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73014-3035ANCALIMA BACITRACIN ZINC FIRST AID (BACITRACIN ZINC) OINTMENT [ANCALIMA LIFESCIENCES LIMITED]2Legacy NDC, 5 package rows20210113_860f9a5f-71f3-4be4-e053-2991aa0ae617.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73014-303573014-3035-2, 73014-3035-3, 73014-3035-4, 73014-3035-5, 73014-3035-6

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
BACITRACIN ZINC89Y4M234ESACTIM

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
b8b4d183-ee7a-4c28-e053-2995a90a4c5f860f9a5f-71f3-4be4-e053-2991aa0ae6172021-01-12WarningsExact identifier
spl id: b8b4d183-ee7a-4c28-e053-2995a90a4c5f
spl set id: 860f9a5f-71f3-4be4-e053-2991aa0ae617

Reported adverse events (FAERS/openFDA)#

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