FDA.reportPublic FDA data

Major Bacitracin Zinc Ointment

Manufacturer
Major Pharmaceuticals | Trifecta Pharmaceuticals USA LLC
Effective date
2022-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:13:35

Label at a glance#

ProductMajor Bacitracin Zinc
Active ingredientBACITRACIN ZINC
Label structure13 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 the 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

Avoid excessive heat and humidity Store at room temperature 15° to 30°C (59° to 86°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500

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.

Do Not Use

OTC - DO NOT USE SECTION

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

Stop Use and Ask Doctor if

OTC - STOP USE SECTION

  • Before use in case of deep puncture wounds, animal bites or serious burns
  • The condition persists or gets worse
  • A rash or allergic reaction develops

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Apply a small amount of the 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, white petrolatum

Questions

OTC - QUESTIONS SECTION

Call 1-800-616-2471

Storage Information

STORAGE AND HANDLING SECTION

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

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 (1-800-222-1222) right away.

Other Information

SPL UNCLASSIFIED SECTION

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cardinal bacitracin zinccardinal bacitracin zinc

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0904-8804-672023-08-07C16284748780-10191ceaa-6a93-198a-e063-dbdaa90aec3eMajor Bacitracin Zinc Ointment
0904-8804-672023-07-28C16284748780-10191ceaa-6a93-198a-e063-dbdaa90aec3eMajor Bacitracin Zinc Ointment

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-8804-67EA - Each0904-8804d9232ed4-e8e2-4b02-9a83-aafb08a1926012020-09-14

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
0904-88040904-8804-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
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
0d8838a2-23f9-280c-e063-6294a90a3080a6cb8abe-c009-2674-e053-2a95a90a2d5c2023-12-27WarningsExact identifier
spl set id: a6cb8abe-c009-2674-e053-2a95a90a2d5c

Reported adverse events (FAERS/openFDA)#

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