FDA.reportPublic FDA data

Cardinal Health

Manufacturer
Cardinal Health
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:25

Label at a glance#

ProductCardinal Health First Aid Antibiotic
Active ingredientBACITRACIN ZINC
Label structure8 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 this product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily May be covered with a sterile bandage

Label contents#

Full prescribing information#

Active ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (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.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • in case of deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

do not use longer than 1 week unless directed by a doctor


Stop use and ask a doctor if

OTC - STOP USE SECTION

the condition persists or gets worse. If a rash or other allergenic 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


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

Other information

SPL UNCLASSIFIED SECTION

  • do not use if seal is punctured or damaged
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hard Paraffin, Liquid Paraffin, White Soft Paraffin


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bacitracin Zinc Ointment

first aid antibiotic

Cardinal Health

NDC 63517-220-02

Net Wt. 1.0 oz (28.3g)



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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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63517-220-012024-01-30C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-022024-01-30C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-032024-01-30C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-012022-01-13C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-022022-01-13C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-032022-01-13C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-012020-01-31C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-022020-01-31C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts
63517-220-032020-01-31C16284748780-19d75b9d0-20bc-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-220-01Cardinal HealthFirst Aid Antibiotic12 in 1 CASEOINTMENT123
63517-220-01Cardinal HealthFirst Aid Antibiotic144 in 1 BOXOINTMENT1443
63517-220-02Cardinal HealthFirst Aid Antibiotic28.3 g in 1 TUBEOINTMENT28.33
63517-220-02Cardinal HealthFirst Aid Antibiotic100 in 1 CASEOINTMENT1003
63517-220-03Cardinal HealthFirst Aid Antibiotic14.2 g in 1 TUBEOINTMENT14.23
63517-220-03Cardinal HealthFirst Aid Antibiotic100 in 1 CASEOINTMENT1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-220CARDINAL HEALTH FIRST AID ANTIBIOTIC (BACITRACIN ZINC) OINTMENT [CARDINAL HEALTH]3Legacy NDC, 6 package rows20221213_a0b3f819-fd71-451b-b497-bda5609cbfcb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES1
BACITRACINACTIVE MOIETY58H6RWO52I1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1

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
63517-22063517-220-01, 63517-220-02, 63517-220-03

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
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 41 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PARAFFINPARAFFINI9O0E3H2ZETABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, COATED / ORAL0.07 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / RECTAL38 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, EXTENDED RELEASE / ORAL321 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESUSPENSION / TOPICAL11726 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates

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
efa7d4de-8690-3fa2-e053-2995a90abb12a0b3f819-fd71-451b-b497-bda5609cbfcb2022-12-12WarningsExact identifier
spl id: efa7d4de-8690-3fa2-e053-2995a90abb12
spl set id: a0b3f819-fd71-451b-b497-bda5609cbfcb

Reported adverse events (FAERS/openFDA)#

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