FDA.reportPublic FDA data

Bacitracin Zinc

Manufacturer
Dynarex Corporation
Effective date
2011-03-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:27:32

Label at a glance#

ProductBacitracin Zinc
Active ingredientBACITRACIN ZINC
Label structure11 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 the finger) on the area 1-3 times daily. may be covered with a sterile bandage

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                   Purpose           
Bacitracin Zinc 500 Units                Antibactrerial

Uses Bacitracin:

OTC - PURPOSE SECTION

First aid to help prevent infection in:
  • Minor cuts
  • scrapes
  • burns

Ask a doctor before use:

OTC - ASK DOCTOR SECTION

  • in case of deep or puncture wounds, animal bites and serious burns
  • if the condition persists or gets worse
  • if a rash or any other allergic reaction develops

Other information

SPL UNCLASSIFIED SECTION

  • store at controlled room temperature 15°-30° C (59°-86° F)
  • Tamper Evident. Do not use if packet is torn, cut or opened.

Inactive ingredients

INACTIVE INGREDIENT SECTION

White Petrolatum

INDICATIONS & USAGE SECTION


Indications and Usage

  • For first aid to help prevent infection in minor skin abrasions and rashes.

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 the finger) on the area 1-3 times daily.
  • may be covered with a sterile bandage

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.

WARNINGS SECTION

  • for external use only

   

Do not use:

OTC - DO NOT USE SECTION

Do not use:

  • in the eyes
  • over large area of the body
  • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock
  • longer than 1 week unless directed by a doctor

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

bacitracinbacitracin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN3
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD3
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-238-012019-10-29C16284748780-1960f7f55-c488-8e05-e053-dbdaa90a074aBacitracin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-238-01Bacitracin Zinc12 in 1 CASEOINTMENT123
67777-238-01Bacitracin Zinc144 in 1 BOXOINTMENT1443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-238BACITRACIN ZINC OINTMENT [DYNAREX CORPORATION]3Legacy NDC, 2 package rows20110324_352a3f20-e8cb-42d4-8977-9ce82b8f324c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES3
BACITRACIN ZINCACTIVE MOIETY89Y4M234ES3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U3

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-23867777-238-01

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
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates

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
3865719d-c769-45ea-b91a-126f78dfd72a352a3f20-e8cb-42d4-8977-9ce82b8f324c2011-03-23WarningsExact identifier
spl id: 3865719d-c769-45ea-b91a-126f78dfd72a
spl set id: 352a3f20-e8cb-42d4-8977-9ce82b8f324c

Reported adverse events (FAERS/openFDA)#

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