FDA.reportPublic FDA data

Bacitracin 500units

Manufacturer
Pharmaceutica North America, Inc.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:46:51

Label at a glance#

ProductBacitracin 500units
Active ingredientBACITRACIN
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin 500 units

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to:
• simple backache
• arthritis
• strains
• sprains

Warnings

WARNINGS SECTION

For external use only.
Do not use
• in the eyes
• on large areas of the body
• if you are allergic to any of the ingredients
Ask a doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns
Stop use and ask a doctor if
• you need to use longer than 1 week
• condition persists or gets worse
• rash or other allergic reaction develops
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

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

Other information

SPL UNCLASSIFIED SECTION

• Store at 20° - 25°C (68° - 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

light mineral oil, white petrolatum

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45861-073-03GM - Gram45861-073c8705e0e-e7e8-4c95-aa1e-a77e71626c4e12025-05-14

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
45861-07345861-073-03

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
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN58H6RWO52IACTIB

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
471bdf68-b865-096f-e063-6294a90a84d1b8d44e8a-c36a-4b12-9b76-ba6f0d6534552025-12-29WarningsExact identifier
spl id: 471bdf68-b865-096f-e063-6294a90a84d1
spl set id: b8d44e8a-c36a-4b12-9b76-ba6f0d653455

Reported adverse events (FAERS/openFDA)#

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