FDA.reportPublic FDA data

DR BELLS POMADE

Manufacturer
Genomma lab USA Inc. | Faria LLC dba Sheffield Pharmaceuticals
Effective date
2014-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:06

Label at a glance#

ProductDR BELLS POMADE
Active ingredientBacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, PRAMOXINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

First aid helps prevent infection in and temporarily relieves pain due to: cuts scrapes burns

Dosage and administration

Adults and children 2 years and older. clean the affected area apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily. may be covered with a sterile bandage Children 2 years and under ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Uses

INDICATIONS & USAGE SECTION

First aid helps prevent infection in and temporarily relieves pain due to:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Allergy Alert:  Do not use if allergic to any of the ingredients

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes or nose
  • on large areas of the body

Consult a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not use longer than 1 week

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older.

  • clean the affected area
  • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Children 2 years and under ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive ingredient

INACTIVE INGREDIENT SECTION

White Petrolatum

Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

POMADA DE LA CAMPANA

Originial Ointment 

First Aid Antibiotic + Pain Relief Ointment

NET WT. 0.5 oz ( 14g)

Principal Display Panel – Carton LabelPrincipal Display Panel – Carton Label

Principal Display Panel – Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Tube LabelPrincipal Display Panel – Tube Label

POMADA DE LA CAMPANA

Originial Ointment

First Aid Antibiotic + Pain Relief Ointment

Triple Antibiotic + Pain Relief

  • Bacitracin Zinc
  • Neomycin Sulfate 
  • Polymixin B Sulfate
  • Pramoxine HCL

NET WT. 0.5 oz ( 14g)

 

 

 

 


 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN1
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD1
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN 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
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-161-512020-01-31C16284748780-19d75b9cf-f1ca-f424-e053-dadaa90a57ce5f1491f0-abea-4852-93f3-d5b22c3c5a94

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-161-51DR BELLS POMADE14 g in 1 TUBEOINTMENT141
50066-161-51DR BELLS POMADE1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-161DR BELLS POMADE (TRIPLE ANTIBIOTIC PLUS PAIN RELIEF) OINTMENT [GENOMMA LAB USA INC.]1Legacy NDC, 2 package rows20140113_5f1491f0-abea-4852-93f3-d5b22c3c5a94.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ES1
Neomycin SulfateACTIVE INGREDIENT057Y6266931
Polymyxin B SulfateACTIVE INGREDIENT19371312D41
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L51
BacitracinACTIVE MOIETY58H6RWO52I1
NeomycinACTIVE MOIETYI16QD7X2971
Polymyxin BACTIVE MOIETYJ2VZ07J96K1
PRAMOXINEACTIVE MOIETY068X84E0561
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-16150066-161-51

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
Polymyxin B Sulfate19371312D4ACTIM
Neomycin Sulfate057Y626693ACTIM
Petrolatum4T6H12BN9UIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact 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
671d14d7-d8b7-4999-94ac-727cb237b5645f1491f0-abea-4852-93f3-d5b22c3c5a942014-01-10WarningsExact identifier
spl id: 671d14d7-d8b7-4999-94ac-727cb237b564
spl set id: 5f1491f0-abea-4852-93f3-d5b22c3c5a94

Reported adverse events (FAERS/openFDA)#

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