Bacitracin Zinc Ointment USP

Manufacturer
A-S Medication Solutions
Effective date
2017-09-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 01:11:46

Label at a glance#

ProductBacitracin Zinc
Active ingredientBACITRACIN ZINC
Label structure11 sections

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

Antibiotic

INDICATIONS & USAGE SECTION

Uses:

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings: For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Ask doctor before use in case of deep or puncture wounds, animal bites or serious burns

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if 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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • 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

SPL UNCLASSIFIED SECTION

Other information:

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
  • store at room temperature
  • see crimp of tube for Lot Number and Exp. Date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

white petrolatum

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0360

NDC: 50090-0360-0 14.17 g in a TUBE

bacitracin zinc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128240900099876541299lbl500900360.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0011-04GM - Gram0168-00114183200d-0ee7-44ec-a61d-ccb0d96daa2612012-07-24
0168-0011-16GM - Gram0168-0011aa72cf65-9ace-4b68-8623-723b2ad7296f12012-07-24
0168-0011-31GM - Gram0168-0011663eb974-383e-42dd-a023-a6f3912a99ed12012-07-24
0168-0011-35GM - Gram0168-0011b803f724-f27a-4037-8869-cb8b8f139d2e12012-07-24

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
50090-036050090-0360-0
0168-0011

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
0cd97d90-420f-45ca-bdb5-b3e10f5cf56a08219765-7990-4618-bce3-7aa17271f4d02017-09-27WarningsExact identifier
spl id: 0cd97d90-420f-45ca-bdb5-b3e10f5cf56a
spl set id: 08219765-7990-4618-bce3-7aa17271f4d0

Reported adverse events (FAERS/openFDA)#

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