FDA.reportPublic FDA data

CR-1163 Bacitracin Ointment with Zinc, NDC 70000-0470-1

Manufacturer
Cardinal Health
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:13:56

Label at a glance#

ProductBacitracin With Zinc
Active ingredientBACITRACIN ZINC
Label structure9 sections

Indications and uses

first aid to help prevent infection in minor cuts, scrapes, and 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 a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (500 units in each gram)

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

the condition persists or gets worse, or if a rash or other allergic reaction develops

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.

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

STORAGE AND HANDLING SECTION

store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Questions and comments?

OTHER SAFETY INFORMATION

1-888-396-2739

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR1163 Primary Display PanelCR1163 Primary Display Panel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0470BACITRACIN WITH ZINC (FIRST AID ANTIBIOTIC) OINTMENT [CARDINAL HEALTH]6Legacy NDC20240119_80af2e5e-ddfe-a1d6-e053-2991aa0a2227.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0470-1GM - Gram70000-0470998b9ebd-309d-4bc2-a5be-2d688902bbca12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-047070000-0470-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIB
MINERAL OILT5L8T28FGPIACT

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
3a868d88-5538-65d5-e063-6394a90a8a9e80af2e5e-ddfe-a1d6-e053-2991aa0a22272025-07-22WarningsExact identifier
spl set id: 80af2e5e-ddfe-a1d6-e053-2991aa0a2227

Reported adverse events (FAERS/openFDA)#

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