FDA.reportPublic FDA data

SUPER BIOTIC WOUND OINTMENT

Manufacturer
Cintas First Aid & Safety | Safetec of America, Inc.
Effective date
2010-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:25:57

Label at a glance#

ProductFirst Aid Triple Antibiotic with Pain Reliever
Active ingredientbacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine
Label structure11 sections

Dosage and administration

Adults and children 2yrs. And older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily, may cover with a sterile bandage Children under 2: Ask a Doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FIRST AID
TRIPLE ANTIBIOTIC
With PAIN RELIEVER

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc (400 units bacitracin

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Lidocaine 40mg

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Anesthetic

INDICATIONS & USAGE SECTION

Uses First aid to help prevent infection and provide temporary relief in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in eyes
  • over large areas of the body
  • in case of deep or puncture wounds, animal bites or serious burns
  • if allergic to ingredients
  • longer than 1 week unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if condition gets worse or a rash or other allergic reactions occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If ingested, contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2yrs. And older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily, may cover with a sterile bandage
  • Children under 2: Ask a Doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum

PRINCIPLE DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUPER
BIOTIC
WOUND OINTMENT

#100210

FIRST AID
TRIPLE ANTIBIOTIC
WITH PAIN RELIEVER

0.7g (1/41 oz.)

Mfd for FAD
First Aid Direct
Mason, OH 45040

Active ingredients (in each gram)
Bacitracin zinc (400 units Bacitracin)
Neomycin sulfate (3.5 mg neomycin)
Polymyxin B sulfate (5000 units)
Lidocaine 40 mg

Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
Anesthetic

Uses First aid to help prevent infection and provide temporary relief in minor cuts, scrapes, and burns

PRINCIPLE DISPLAY PANEL - SUPER BIOTIC WOUND OINTMENT
PRINCIPLE DISPLAY PANEL - SUPER BIOTIC WOUND OINTMENT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098397bacitracin 400 UNT / lidocaine 40 MG / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN2
1098397bacitracin 0.4 UNT/MG / lidocaine 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2
1098397bacitracin 400 UNT / lidocaine 40 MG / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68421-6500-02020-01-31C16284748780-19d75b9d1-0c75-f424-e053-dadaa90a57ceSUPER BIOTIC WOUND OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68421-6500-0First Aid Triple Antibiotic with Pain Reliever0.7 g in 1 POUCHOINTMENT0.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68421-6500FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [CINTAS FIRST AID & SAFETY]2Legacy NDC, 1 package rows20100930_fc0dc0be-1d9b-4ff0-ab48-b0fdd7b1cfce.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ES2
lidocaineACTIVE INGREDIENT98PI2009872
neomycin sulfateACTIVE INGREDIENT057Y6266932
polymyxin b sulfateACTIVE INGREDIENT19371312D42
bacitracin zincACTIVE MOIETY89Y4M234ES2
lidocaineACTIVE MOIETY98PI2009872
neomycinACTIVE MOIETYI16QD7X2972
polymyxin bACTIVE MOIETYJ2VZ07J96K2
petrolatumINACTIVE INGREDIENT4T6H12BN9U2

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
68421-650068421-6500-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
bacitracin zinc89Y4M234ESACTIB
neomycin sulfate057Y626693ACTIB
polymyxin b sulfate19371312D4ACTIB
lidocaine98PI200987ACTIB
petrolatum4T6H12BN9UIACT

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 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
c514a8d6-f62a-4acb-ad42-2df85edb3b7cfc0dc0be-1d9b-4ff0-ab48-b0fdd7b1cfce2010-09-15WarningsExact identifier
spl id: c514a8d6-f62a-4acb-ad42-2df85edb3b7c
spl set id: fc0dc0be-1d9b-4ff0-ab48-b0fdd7b1cfce

Reported adverse events (FAERS/openFDA)#

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