FDA.reportPublic FDA data

Drs. Antibiotic Bacitracin

Manufacturer
OL PHARMA TECH, LLC | OL PHARMA TECH, LLC Drs PHARMACY
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:16

Label at a glance#

ProductDrs. Antibiotic Bacitracin
Active ingredientBACITRACIN ZINC
Label structure13 sections

Indications and uses

First aid to help prevent infection in : minor cuts burns scrapes

Dosage and administration

Directions clean the affected area and dry thoroughly 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 room temperature see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 500 units in one gram

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in :

  • minor cuts
  • burns
  • scrapes

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use
• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body
• longer than 1 week unless directed by a doctor

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use

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

Stop use

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition persists or gets worse
  • a rash or other allergic reaction develops

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the affected area and dry thoroughly
  • 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

OTHER SAFETY INFORMATION

  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredient

INACTIVE INGREDIENT SECTION

Petrolatum

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 right away

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibiotic ointmentAntibiotic ointmentDrs. Bacitracin Antibiotic ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN4
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD4
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-006-01Drs. Antibiotic Bacitracin1 in 1 CARTONOINTMENT14
80489-006-01Drs. Antibiotic Bacitracin14 g in 1 TUBEOINTMENT144
80489-006-02Drs. Antibiotic Bacitracin1 in 1 CARTONOINTMENT14
80489-006-02Drs. Antibiotic Bacitracin28.3 g in 1 TUBEOINTMENT28.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-006DRS. ANTIBIOTIC BACITRACIN (BACITRACIN) OINTMENT [OL PHARMA TECH, LLC]4Current NDC, Legacy NDC, 4 package rows20250112_c26493c4-0bc1-5fdc-e053-2995a90a81e6.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-00680489-006-01, 80489-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN ZINC89Y4M234ESACTIM
PETROLATUM4T6H12BN9UIACT

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
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
ndc (package): 80489-006-01
ndc (package): 80489-006-02
ndc (product): 80489-006
ndc11 (package): 80489000601
ndc11 (package): 80489000602
spl id: 2b5219ec-a6ca-f405-e063-6294a90ab2c6
spl set id: c26493c4-0bc1-5fdc-e053-2995a90a81e6

Reported adverse events (FAERS/openFDA)#

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