FDA.reportPublic FDA data

BACITRACIN ZINC

Manufacturer
STRATUS PHARMACEUTICALS INC | TARMAC PRODUCTS INC
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:33:59

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 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 May be covered with a sterile bandage

Storage and handling

Store at room temperature 59°F - 77°F (15°C - 25°C) Before using any medication, read all label directions. Keep carton, it contains important information. Do not use if seal is punctured or is not visible See crimp of tube and outside of carton for Lot Number and Expiration Date. To open, reverse cap and puncture.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc, USP 500 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

Allergy alert

SPL UNCLASSIFIED SECTION

  • do not use if allergic to any of the ingredients

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not use longer then one week unless directed by doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 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
  • May be covered with a sterile bandage

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature 59°F - 77°F (15°C - 25°C)
  • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Do not use if seal is punctured or is not visible
  • See crimp of tube and outside of carton for Lot Number and Expiration Date.
  • To open, reverse cap and puncture.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

White petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by: Stratus Pharmaceuticals Inc.
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STRATUSCARE
NDC 58980-011-10

Bacitracin Zinc Ointment USP

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 g)

Distributed by:
STRATUS
PHARMACEUTICALS INC

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

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

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
58980-011-01BACITRACIN ZINC144 in 1 BOXOINTMENT1443
58980-011-01BACITRACIN ZINC1 g in 1 PACKETOINTMENT13
58980-011-10BACITRACIN ZINC1 in 1 BOXOINTMENT13
58980-011-10BACITRACIN ZINC28.35 g in 1 TUBEOINTMENT28.353

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-011BACITRACIN ZINC OINTMENT [STRATUS PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 4 package rows20241105_b2cb3a96-b0ca-42ee-8056-91d5450fb376.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-011-01GM - Gram58980-011ed1efaa5-281e-49da-b478-d773777e69a512020-06-05
58980-011-10GM - Gram58980-011435dc26d-b088-408a-aa6e-5d766734c9db12018-09-05

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58980-01158980-011-10, 58980-011-01

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
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
BACITRACIN ZINCBACITRACIN ZINCSTRATUS PHARMACEUTICALS INCb2cb3a96-b0ca-42ee-8056-91d5450fb3762024-10-31WarningsExact identifier
ndc (package): 58980-011-01
ndc (package): 58980-011-10
ndc (product): 58980-011
ndc11 (package): 58980001101
ndc11 (package): 58980001110
spl id: 989398c9-b804-46c7-b8bf-20d9dabcb245
spl set id: b2cb3a96-b0ca-42ee-8056-91d5450fb376

Reported adverse events (FAERS/openFDA)#

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