FDA.reportPublic FDA data

Bacitracin Zinc 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#

ProductBacitracin Zinc
Active ingredientBACITRACIN ZINC
Label structure12 sections

Indications and uses

First aid to help prevent infection in scrapes   minor cuts burns

Dosage and administration

clean 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

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500 units

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

USES

INDICATIONS & USAGE SECTION

First aid to help prevent infection in

  • scrapes  
  • minor cuts
  • burns

WARNINGS

WARNINGS SECTION

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

Before using, consult a doctor if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites   
  • serious burns

STOP USE and ask a doctor if

OTC - STOP USE SECTION

  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persists for more than 1 week or clear up and occur again within a few days 
  • a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • clean 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° to 25°C (59° to 77°F).  
  • Before using any medication, read all label directions.

Keep carton, it contains important information.

Lot No./Exp. Date: see crimp of tube.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bacitracin Zinc Ointment

NET WT 0.5 OZ (14g)

Bacitracin Zinz Ointment
Bacitracin Zinz Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN1
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD1
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY1

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
47046-155-022022-01-28C16284748780-1d6a99b39-808b-a426-e053-dadaa90af4c2Bacitracin Zinc Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-155-01Bacitracin Zinc14 g in 1 TUBEOINTMENT141
47046-155-02Bacitracin Zinc1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-155BACITRACIN ZINC OINTMENT [ANICARE PHARMACEUTICALS PVT. LTD]1Legacy NDC, 2 package rows20201215_b65a2a1e-b5cb-e47d-e053-2995a90a6abc.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-15547046-155-01, 47046-155-02

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
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
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
b65a3425-3169-7d41-e053-2995a90af59db65a2a1e-b5cb-e47d-e053-2995a90a6abc2020-12-13WarningsExact identifier
spl id: b65a3425-3169-7d41-e053-2995a90af59d
spl set id: b65a2a1e-b5cb-e47d-e053-2995a90a6abc

Reported adverse events (FAERS/openFDA)#

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