FDA.reportPublic FDA data

Cardinal Health

Manufacturer
Cardinal Health
Effective date
2022-01-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:17:46

Label at a glance#

ProductCardinal Health First Aid Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
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 ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (400 units)

Neomycin Sulfate (5mg equivalent to 3.5 mg Neomycin base)

Polymyxin B Sulfate (5,000 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

White Soft Paraffin


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 63517-216-05

Triple Antibiotic Ointment

Neomycin Sulfate, Polymyxin B Sulfate, and Bacitracin Zinc Ointment USP

first aid antibiotic

CardinalHealth

Net Wt 1.0 oz (28.3g)

LabelLabel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266931
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D41
BACITRACINACTIVE MOIETY58H6RWO52I1
NEOMYCINACTIVE MOIETYI16QD7X2971
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63517-21663517-216-01, 63517-216-05, 63517-216-02

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
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM

Source Document#

Source XML · Source PDF

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 · 11 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
PARAFFINPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, COATED / ORAL0.07 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 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
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / RECTAL38 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, EXTENDED RELEASE / ORAL321 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 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
efe1a0f9-ed18-54d7-e053-2a95a90afb80dc83493b-0381-4ba8-a3f7-cb2dc41e5d872022-12-15WarningsExact identifier
spl set id: dc83493b-0381-4ba8-a3f7-cb2dc41e5d87

Reported adverse events (FAERS/openFDA)#

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