Pomada de Sulfa

Manufacturer
Menper Distributors, Inc. | World Perfumes Inc
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:13

Label at a glance#

ProductPomada de Sulfa
Active ingredientNEOMYCIN SULFATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each gram)

Neomycin  3.5 mg

OTC - PURPOSE SECTION

Purpose

First aid antibiotic

INDICATIONS & USAGE SECTION

Uses

first aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings

For external use only

Do not use

  • in the eyes or apply over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask a doctor before usein case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reactions develop

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

methylparaben, propylparaben, vitamin E, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pomada de Sulfa LabelPomada de Sulfa Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311928neomycin 0.35 % Topical OintmentPSN5
311928neomycin 0.0035 MG/MG Topical OintmentSCD5
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSY5
311928neomycin 0.35 % Topical OintmentSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-056-022023-07-28C16284748780-19d75b9d0-1e04-f424-e053-dadaa90a57cePomada de Sulfa
53145-056-022021-08-14C16284748780-19d75b9d0-1e04-f424-e053-dadaa90a57cePomada de Sulfa
53145-056-022020-01-31C16284748780-19d75b9d0-1e04-f424-e053-dadaa90a57cePomada de Sulfa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-056-02Pomada de Sulfa57 g in 1 JAROINTMENT575
53145-056-02Pomada de Sulfa1 in 1 PACKAGEOINTMENT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266931
NEOMYCINACTIVE MOIETYI16QD7X2971
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1

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
53145-05653145-056-02

Ingredients#

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

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

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…

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
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact identifier
ndc (package): 53145-056-02
ndc (product): 53145-056
ndc11 (package): 53145005602
spl id: 3a8a3022-d082-1ccf-e063-6394a90a90ed
spl set id: 216f4d22-e5e8-46c8-a4ef-8d1532792b56

Reported adverse events (FAERS/openFDA)#

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