FDA.reportPublic FDA data

Polvos de Sulpha

Manufacturer
Menper Distributors Inc. | Lex Pharma
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:52:40

Label at a glance#

ProductPolvos de Sulpha First Aid Antibiotic
Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure12 sections

Indications and uses

first aid to help prevent infection in minor  cuts scrapes burns

Dosage and administration

clean the affected area  apply a light dusting of the powder on the area 1 to 3 times daily  may be covered with a sterile bandages children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (each gram contains) Purpose

Bacitracin zinc 500 units.....................................................................................First aid

Polymyxin B sulfate 10,000 units.........................................................................First aid antibiotic

Purpose 

OTC - PURPOSE SECTION

First aid

First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor 

  • cuts
  • scrapes
  • burns

WARNINGS SECTION

For fexternal use only

Ask a doctor before use if you have 

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if 

OTC - STOP USE SECTION

The condition persists or gets worsen 

a rash or other alergic reaction develops

Keep out of reach of childrens 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions Adults and children 2 years of age and older 

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area 
  • apply a light dusting of the powder on the area 1 to 3 times daily 
  • may be covered with a sterile bandages children under 2 years of age: consult a doctor

Other Information 

OTHER SAFETY INFORMATION

  • store at 15° to 25° C (59° to 86° F)
  • do not refrigerate

Tamper-Evident: Do not use if there is evidence of tampering 

Inactive ingredients 

INACTIVE INGREDIENT SECTION

Lactose 

Questions?

OTC - QUESTIONS SECTION

1-800-560-5223 M-F 9 AM to 5 PM Eastern Time 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308513bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical PowderPSN12
308513bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical PowderSCD12
308513bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM Topical PowderSY12

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-304-042023-10-19C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042023-07-28C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042022-02-18C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042022-01-28C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042020-02-07C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042020-01-31C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-304-04Polvos de SulphaFirst Aid Antibiotic7.5 g in 1 BOTTLE, PLASTICPOWDER7.512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53145-304POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]12Legacy NDC, 1 package rows20250116_511b52e9-c112-4519-a567-dc9f433c4f37.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES4
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D44
BACITRACIN ZINCACTIVE MOIETY89Y4M234ES4
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G4

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-30453145-304-04

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
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
BACITRACIN ZINC89Y4M234ESACTIM
POLYMYXIN B SULFATE19371312D4ACTIM

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GPOWDER / RESPIRATORY (INHALATION)90 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCREAM / VAGINAL3 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCONCENTRATE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GOINTMENT / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, CHEWABLE / ORAL1412 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / RECTAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY193.8 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 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
2b362c67-d115-fb81-e063-6394a90aeb65511b52e9-c112-4519-a567-dc9f433c4f372025-01-08WarningsExact identifier
spl id: 2b362c67-d115-fb81-e063-6394a90aeb65
spl set id: 511b52e9-c112-4519-a567-dc9f433c4f37

Reported adverse events (FAERS/openFDA)#

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