FDA.reportPublic FDA data

Biotic-Plus

Manufacturer
Provision Medical | Safetec of America, Inc.
Effective date
2014-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:48

Label at a glance#

ProductBiotic-Plus
Active ingredientbacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine
Label structure8 sections

Indications and uses

First aid to help prevent infection and provide temporary relief in minor cuts, scrapes, and burns The Provision First Aid Line Manufactured for Provision Medical Products Palm Desert, CA 92211

Dosage and administration

adults & children 2 years & older: clean affected area, apply amount (equal to surface area of a tip of finger) on area 1-3 times daily. May be covered with a sterile bandage. children under 2: do not use, ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

advanced Stops Pain and Prevents Infection for Cuts and Scrapes

BIOTIC-PLUS       0.5g

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each gram)

Bacitracin zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Lidocaine .40 mg

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Anesthetic

Uses

INDICATIONS & USAGE SECTION

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

The Provision First Aid Line

Manufactured for Provision Medical Products Palm Desert, CA 92211

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, contact a Poison Control Center directly.

Do not use

OTC - DO NOT USE SECTION

  • in eyes or over large areas of the body
  • more than 1 week unless directed by a doctor
  • if allergic to ingredients.

Stop use, ask a doctor

OTC - STOP USE SECTION

  • in case of deep or puncture wounds, animal bites or serious burns
  • if conditions worsen or last more than 7 days
  • if rash or allergic reaction occurs

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults & children 2 years & older: clean affected area, apply amount (equal to surface area of a tip of finger) on area 1-3 times daily. May be covered with a sterile bandage.
  • children under 2: do not use, ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel
Principal Display Panel

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 OintmentPSN1
1098397bacitracin 0.4 UNT/MG / lidocaine 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1
1098397bacitracin 400 UNT / lidocaine 40 MG / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69103-2400-12020-01-31C16284748780-19d75b9d0-9fd3-f424-e053-dadaa90a57ce0d3af5c2-e24a-4070-a059-5f7ceacb6540

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69103-2400-1Biotic-Plus0.5 g in 1 POUCHOINTMENT0.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69103-2400BIOTIC-PLUS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [PROVISION MEDICAL]1Legacy NDC, 1 package rows20140728_0d3af5c2-e24a-4070-a059-5f7ceacb6540.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ES1
lidocaineACTIVE INGREDIENT98PI2009871
neomycin sulfateACTIVE INGREDIENT057Y6266931
polymyxin b sulfateACTIVE INGREDIENT19371312D41
bacitracinACTIVE MOIETY58H6RWO52I1
lidocaineACTIVE MOIETY98PI2009871
neomycinACTIVE MOIETYI16QD7X2971
polymyxin bACTIVE MOIETYJ2VZ07J96K1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69103-240069103-2400-1

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 zinc89Y4M234ESACTIM
neomycin sulfate057Y626693ACTIM
polymyxin b sulfate19371312D4ACTIM
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
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact 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
petrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact 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
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact 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
294cef14-6b97-4221-9f9e-13e9529194ff0d3af5c2-e24a-4070-a059-5f7ceacb65402014-07-24WarningsExact identifier
spl id: 294cef14-6b97-4221-9f9e-13e9529194ff
spl set id: 0d3af5c2-e24a-4070-a059-5f7ceacb6540

Reported adverse events (FAERS/openFDA)#

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