FDA.reportPublic FDA data

Lincoln

Manufacturer
Lincoln Pharmaceutical Ltd.
Effective date
2016-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:40

Label at a glance#

ProductLincoln
Active ingredientPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN ZINC
Label structure12 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 400 units- Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin) Polymyxin B sulfate 5000 units

Drug Facts

OTC - PURPOSE SECTION

First Aid antibiotic

Drug Facts

INDICATIONS & USAGE SECTION

Uses

  • First aid to prevent infection in
  • minor cuts
  • scrapes
  • burns

Drug Facts

WARNINGS SECTION

For External use only

Drug Facts

OTC - DO NOT USE SECTION

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

Drug Facts

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Drug Facts

OTC - STOP USE SECTION

  • the condition persists or get worse
  • a rash or other allergic reaction develops

Drug Facts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Drug Facts

DOSAGE & ADMINISTRATION SECTION

  • 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 sterile bandage

OTHER SAFETY INFORMATION

  • store at room temperature 15- 30° C (59-86F)
  • avoid excessive heat and humidity

Drug Facts

INACTIVE INGREDIENT SECTION

white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal displayprincipal display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT 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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69636-3025-22020-01-31C16284748780-19d75b9d1-273c-f424-e053-dadaa90a57ce2fae7dd2-1d15-0459-e054-00144ff88e88
69636-3025-32020-01-31C16284748780-19d75b9d1-273c-f424-e053-dadaa90a57ce2fae7dd2-1d15-0459-e054-00144ff88e88
69636-3025-42020-01-31C16284748780-19d75b9d1-273c-f424-e053-dadaa90a57ce2fae7dd2-1d15-0459-e054-00144ff88e88
69636-3025-52020-01-31C16284748780-19d75b9d1-273c-f424-e053-dadaa90a57ce2fae7dd2-1d15-0459-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69636-3025-2Lincoln0.5 g in 1 PACKETOINTMENT0.51
69636-3025-3Lincoln0.9 g in 1 PACKETOINTMENT0.91
69636-3025-4Lincoln14 g in 1 TUBEOINTMENT141
69636-3025-5Lincoln28.3 g in 1 TUBEOINTMENT28.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69636-3025LINCOLN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [LINCOLN PHARMACEUTICAL LTD.]1Legacy NDC, 4 package rows20160409_2fae7dd2-1d15-0459-e054-00144ff88e88.zip

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
69636-302569636-3025-2, 69636-3025-3, 69636-3025-5, 69636-3025-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
POLYMYXIN B SULFATE19371312D4ACTIM
NEOMYCIN SULFATE057Y626693ACTIM
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML

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
2fae7dd2-1d16-0459-e054-00144ff88e882fae7dd2-1d15-0459-e054-00144ff88e882016-04-08WarningsExact identifier
spl id: 2fae7dd2-1d16-0459-e054-00144ff88e88
spl set id: 2fae7dd2-1d15-0459-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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